PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Report

• Report Number: 1020279-2025-01707
• Event Type: Injury
• Date Received: October 15, 2025
• Report Date: May 19, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: JWH
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: AS
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

H11: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT 1020279-2025-01707, PREVIOUSLY SUBMITTED ON 15-OCT-2025. SPECIFICALLY, THE 'UDI NUMBER' FIELDS IN THE .CSV FILE HAVE BEEN UPDATED FOR THE LINE ITEMS LABELED AS 'VERSION 1' IN COLUMN AE ('LATEST LINE-ITEM VERSION'). THESE UPDATES APPLY TO THE FOLLOWING COMPLAINTS AND REPLACE THE VALUES PREVIOUSLY PROVIDED: (B)(4). NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE .CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT 1020279-2025-01707.

Additional Manufacturer Narrative · 0

CORRECTED DATA: A2 (AGE AT THE TIME OF EVENT CORRECTED FROM 64 YEARS TO 68 YEARS), B5 (EVENT NARRATIVE), H2 (TOTAL QUANTITY OF SUMMARIZED EVENTS IS NOW 6638). H11: THE SUBMISSION CONSOLIDATES PREVIOUSLY REPORTED CASES AND NEW CASES INTO A SINGLE DATASET PER FDA¿S (B)(4) EXEMPTION GUIDANCE. OF THE 6638 REVISIONS, 4875 WERE INCLUDED IN PRIOR QUARTERLY SUBMISSIONS FOR THE SAME REGISTRY AND ARE RE LISTED HERE FOR COMPLETENESS AND ALIGNMENT. NO ADDITIONAL CASE LEVEL INFORMATION BEYOND WHAT WAS ALREADY PROVIDED IS AVAILABLE FOR THOSE 4875 EVENTS. A TOTAL OF 1763 NEW CASES WERE PROVIDED DURING THIS QUARTER, THEREFORE, A TOTAL OF 6638 REVISION PROCEDURES ARE SUMMARIZED IN THIS SUBMISSION. REPORTING QUARTER: 2 (APRIL 1 - JUN 30, 2025) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AOANJRR, SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN KNEE REPLACEMENT SURGERIES. 1. PRIMARY UKA PROCEDURES: - GENESIS UNI FEMORAL COMPONENTS: IMPLANTED IN TWO THOUSAND ONE HUNDRED AND NINETY-EIGHT (2,198) KNEES BETWEEN (B)(6) 1999 AND (B)(6) 2014. THESE INCLUDE SIZE VARIANTS CERTIFIED FOR USE IN THE UNITED STATES UNDER PRO CODES HSX, JWH AND JDI. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FIVE HUNDRED SIX (506) CASES DUE TO THE FOLLOWING COMPLICATIONS: ONE HUNDRED AND EIGHTY-SEVEN (187) KNEES DUE TO PROGRESSION OF DISEASE, TWO HUNDRED AND EIGHTEEN (218) KNEES DUE TO LOOSENING, THIRTY (30) KNEES DUE TO PAIN, TWELVE (12) KNEES DUE TO INFECTION, FOURTEEN (14) KNEES DUE TO LYSIS, THREE (3) KNEES DUE TO FRACTURE, NINE (9) KNEES DUE TO WEAR OF TIBIAL INSERT, FIVE (5) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO MALALIGNMENT, FIVE (5) KNEES DUE TO IMPLANT BREAKAGE ASSOCIATED WITH THE TIBIAL COMPONENT, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, FOUR (4) KNEES DUE TO TIBIAL WEAR, TWO (2) KNEES DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO INCORRECT SIZING, FIVE (5) KNEES DUE TO OSTEONECROSIS, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO PATELLA EROSION AND TWO (2) KNEES DUE TO OTHER-UNSPECIFIED REASONS. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 506 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE JWH. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 506 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF (B)(4) INCLUDES ONLY 376 REVISIONS ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS UNI FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE JWH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 376 CASES. 2. PRIMARY TKA PROCEDURES: JOURNEY II BCS OXINIUM FEMORAL COMPONENTS: IMPLANTED IN FOUR THOUSAND FIVE HUNDRED AND TWENTY-FIVE (4,525) KNEES BETWEEN (B)(6) 2013 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FORTY-FOUR (44) CASES DUE TO THE FOLLOWING COMPLICATIONS: NINETEEN (19) KNEES DUE TO INFECTION, SIX (6) KNEES DUE TO INSTABILITY, FOUR (4) KNEES DUE TO LOOSENING, FOUR (4) KNEES DUE TO PAIN, FOUR (4) KNEES DUE TO FRACTURE, TWO (2) KNEES DUE TO PATELLA EROSION, ONE (1) KNEE DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO WEAR OF THE TIBIAL INSERT, AND ONE (1) KNEE DUE TO SYNOVITIS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. LEGION TOTAL KNEE SYSTEM POROUS TIBIAL BASEPLATES WITHOUT HOLES: IMPLANTED IN FOUR HUNDRED AND SIXTY-EIGHT (468) KNEES BETWEEN (B)(6) 2018 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SIX (6) CASES DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) DUE TO INFECTION, THREE (3) DUE TO LOOSENING, ONE (1) DUE TO PAIN, AND ONE (1) DUE TO PATELLA MALTRACKING. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. LEGION CRUCIATE RETAINING (CR) COBALT-CHROMIUM (COCR) NON-POROUS FEMORAL COMPONENTS: IMPLANTED IN FIVE THOUSAND THREE-HUNDRED AND FIFTEEN (5,315) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN ONE HUNDRED AND FIFTY (150) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTY-SEVEN (57) HIPS DUE TO INFECTION, TWENTY-ONE (21) DUE TO LOOSENING, THIRTEEN (13) DUE TO INSTABILITY, TWELVE (12) DUE TO PAIN, SEVEN (7) DUE TO PATELLOFEMORAL PAIN, SIXTEEN (16) DUE TO PATELLA EROSION, ONE (1) DUE TO FRACTURE, SIX (6) DUE TO ARTHROFIBROSIS, THREE (3) DUE TO LYSIS, FOUR (4) DUE TO MALALIGNMENT, ONE (1) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO PROSTHESIS DISLOCATION, FIVE (5) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) COBALT-CHROMIUM (COCR) NON-POROUS FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN SIX THOUSAND SIX-HUNDRED AND EIGHTY-EIGHT (6,688) KNEES BETWEEN (B)(6) 2008 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWO-HUNDRED AND FORTY-THREE (243) CASES DUE TO THE FOLLOWING COMPLICATIONS: A HUNDRED AND SEVEN (107) KNEES DUE TO INFECTION, FIFTY-ONE (51) DUE TO LOOSENING, SEVENTEEN (17) DUE TO INSTABILITY, EIGHT (8) DUE TO PAIN, FOUR (4) DUE TO PATELLOFEMORAL PAIN, SIX (6) DUE TO PATELLA EROSION, FIFTEEN (15) DUE TO FRACTURE, ELEVEN (11) DUE TO ARTHROFIBROSIS, EIGHT (8) DUE TO MALALIGNMENT, ONE (1) DUE TO METAL RELATED PATHOLOGY, THREE (3) DUE TO INCORRECT SIZING, TWO (2) DUE TO PATELLA MALTRACKING, THREE (3) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO WEAR PATELLA, FIVE (5) DUE TO OTHER CAUSES. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION CRUCIATE RETAINING (CR) OXINIUM FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN THIRTEEN THOUSAND AND NINETY-ONE (13,091) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN THREE HUNDRED AND EIGHTY-ONE (381) CASES DUE TO THE FOLLOWING COMPLICATIONS: EIGHTY-SEVEN (87) KNEES DUE TO INFECTION, SEVENTY-TWO (72) DUE TO LOOSENING, FIFTY-EIGHT (58) DUE TO INSTABILITY, THIRTY-SIX (36) DUE TO PAIN, FOURTEEN (14) DUE TO PATELLOFEMORAL PAIN, FORTY-EIGHT (48) DUE TO PATELLA EROSION, TWELVE (12) DUE TO FRACTURE, TWENTY-FIVE (25) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO WEAR TIBIAL INSERT, TEN (10) DUE TO MALALIGNMENT, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, FIVE (5) DUE TO INCORRECT SIZING, FOUR (4) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL, ONE (1) DUE TO WEAR PATELLA, TWO (2) DUE TO OSTEONECROSIS, TWO (2) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) OXINIUM FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN TWENTY THOUSAND AND FIFTY-FOUR (20,054) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN EIGHT HUNDRED AND FIFTY (850) CASES DUE TO THE FOLLOWING COMPLICATIONS: TWO HUNDRED THREE (203) KNEES DUE TO INFECTION, ONE HUNDRED SEVENTY-FIVE (175) DUE TO LOOSENING, ONE HUNDRED ONE (101) DUE TO INSTABILITY, SIXTY-ONE (61) DUE TO PAIN, FIFTY-FOUR (54) DUE TO PATELLOFEMORAL PAIN, FORTY-SEVEN (47) DUE TO PATELLA EROSION, THIRTY-SEVEN (37) DUE TO FRACTURE, FORTY-EIGHT (48) DUE TO ARTHROFIBROSIS, TEN (10) DUE TO WEAR TIBIAL INSERT, SEVEN (7) DUE TO LYSIS, NINETEEN (19) DUE TO MALALIGNMENT, FORTY-ONE (41) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, SIX (6) DUE TO INCORRECT SIZING, SIX (6) DUE TO PATELLA MALTRACKING, TEN (10) DUE TO BEARING DISLOCATION, SIX (6) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO SYNOVITIS, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL, ONE (1) DUE TO WEAR PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE FEMORAL, FIVE (5) DUE TO OSTEONECROSIS, ONE (1) DUE TO HETEROTOPIC BONE, NINE (9) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION REVISION TIBIAL BASEPLATE: IMPLANTED IN NINE HUNDRED SEVENTY-EIGHT (978) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SEVENTY-EIGHT (78) CASES DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-FOUR (34) KNEES DUE TO INFECTION, TEN (10) DUE TO LOOSENING, EIGHT (8) DUE TO INSTABILITY, FIVE (5) DUE TO PAIN, TWO (2) DUE TO PATELLOFEMORAL PAIN, TWO (2) DUE TO PATELLA EROSION, FIVE (5) DUE TO FRACTURE, TWO (2) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO PATELLA MALTRACKING, SEVEN (7) DUE TO BEARING DISLOCATION, ONE (1) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL TIBIAL BASEPLATES PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) OR CRUCIATE RETAINING (CR) HIGH FLEX INSERTS: IMPLANTED IN SIXTY-TWO THOUSAND FOUR HUNDRED AND THIRTY-ONE (62,431) KNEES BETWEEN (B)(6) 2010 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWO THOUSAND AND SEVENTY-SIX (2,176) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIX HUNDRED NINETEEN (619) KNEES DUE TO INFECTION, FOUR HUNDRED TWENTY-ONE (421) DUE TO LOOSENING, ONE HUNDRED EIGHTY (180) DUE TO INSTABILITY, ONE HUNDRED SEVENTY-THREE (173) DUE TO PAIN, NINETY-SEVEN (97) DUE TO PATELLOFEMORAL PAIN, ONE HUNDRED SIXTY-NINE (169) DUE TO PATELLA EROSION, SEVENTY-NINE (79) DUE TO FRACTURE, ONE HUNDRED FORTY-SEVEN (147) DUE TO ARTHROFIBROSIS, FIFTY-THREE (53) DUE TO MALALIGNMENT, FOURTEEN (14) DUE TO LYSIS, FOURTEEN (14) DUE TO WEAR TIBIAL INSERT, FOUR (4) DUE TO METAL RELATED PATHOLOGY, TWENTY-SEVEN (27) DUE TO INCORRECT SIZING, FIFTY-FOUR (54) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, TWENTY-TWO (22) DUE TO PATELLA MALTRACKING, EIGHTEEN (18) DUE TO BEARING DISLOCATION, TWELVE (12) DUE TO IMPLANT BREAKAGE PATELLA, FOUR (4) DUE TO PROSTHESIS DISLOCATION, SEVEN (7) DUE TO SYNOVITIS, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL, NINE (9) DUE TO WEAR PATELLA, NINE (9) DUE TO OSTEONECROSIS, FOUR (4) DUE TO IMPLANT BREAKAGE FEMORAL, FOUR (4) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO PROGRESSION OF DISEASE, THIRTY-THREE (33) DUE TO OTHER-UNSPECIFIED REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION CONSTRAINED ARTICULAR INSERT: IMPLANTED IN FOUR HUNDRED AND FIFTY (450) KNEES BETWEEN (B)(6) 2007 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN THIRTY-SEVEN (37) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTEEN (15) KNEES DUE TO INFECTION, FIVE (5) DUE TO LOOSENING, FIVE (5) DUE TO INSTABILITY, FOUR (4) DUE TO PAIN, ONE (1) DUE TO PATELLOFEMORAL PAIN, ONE (1) DUE TO PATELLA EROSION, ONE (1) DUE TO FRACTURE, ONE (1) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO PATELLA MALTRACKING, THREE (3) DUE TO BEARING DISLOCATION. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION CRUCIATE RETAINING (CR) DEEP-DISH XLPE INSERT: IMPLANTED IN THREE THOUSAND EIGHT-HUNDRED AND SIX (3,806) KNEES BETWEEN (B)(6) 2018 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SEVENTY-EIGHT (78) CASES DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-ONE (31) KNEES DUE TO INFECTION, TWELVE (12) DUE TO LOOSENING, SIX (6) DUE TO INSTABILITY, FIVE (5) DUE TO PAIN, SEVEN (7) DUE TO PATELLA EROSION, SEVEN (7) DUE TO ARTHROFIBROSIS, TWO (2) DUE TO FRACTURE, TWO (2) DUE TO MALALIGNMENT, TWO (2) DUE TO INCORRECT SIZING, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, TWO (2) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO WEAR PATELLA. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT: IMPLANTED IN FIVE HUNDRED FORTY-SIX (546) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FORTY-EIGHT (48) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIXTEEN (16) KNEES DUE TO INFECTION, EIGHT (8) KNEES DUE TO LOOSENING, FOUR (4) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO PAIN, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO PATELLA EROSION, THREE (3) KNEES DUE TO PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO PATELLA MALTRACKING, AND FIVE (5) KNEES DUE TO BEARING DISLOCATION. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. GENESIS II NON-POROUS CR COCR FEMORAL COMPONENT: IMPLANTED IN EIGHTEEN THOUSAND TWO HUNDRED AND SEVENTY-THREE (18,273) KNEES BETWEEN (B)(6) 1999 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN EIGHT HUNDRED AND EIGHTEEN (818) KNEES DUE TO THE FOLLOWING REASONS: TWO HUNDRED TWENTY-EIGHT (228) KNEES DUE TO INFECTION, ONE HUNDRED FORTY-EIGHT (148) DUE TO LOOSENING, SEVENTY-TWO (72) DUE TO INSTABILITY, EIGHTY-NINE (89) DUE TO PAIN, SIXTY-TWO (62) DUE TO PATELLOFEMORAL PAIN, SEVENTY-SEVEN (77) DUE TO PATELLA EROSION, THIRTY-SEVEN (37) DUE TO FRACTURE, THIRTY-TWO (32) DUE TO ARTHROFIBROSIS, SEVEN (7) DUE TO WEAR TIBIAL INSERT, NINE (9) DUE TO LYSIS, SEVENTEEN (17) DUE TO MALALIGNMENT, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, THREE (3) DUE TO METAL RELATED PATHOLOGY, SEVEN (7) DUE TO INCORRECT SIZING, TEN (10) DUE TO PATELLA MALTRACKING, NINE (9) DUE TO BEARING DISLOCATION, ONE (1) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO WEAR PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE FEMORAL, TWO (2) DUE TO OSTEONECROSIS, AND FIVE (5) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. GENESIS II NON-POROUS PS COCR FEMORAL COMPONENT: IMPLANTED IN TWENTY THOUSAND SIX HUNDRED AND ONE (20,601) KNEES BETWEEN (B)(6) 1999 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN NINE HUNDRED AND FORTY-FIVE (945) KNEES DUE TO THE FOLLOWING REASONS: THREE HUNDRED TWO (302) KNEES DUE TO INFECTION, ONE HUNDRED EIGHTY-FOUR (184) DUE TO LOOSENING, SIXTY-FOUR (64) DUE TO INSTABILITY, ONE HUNDRED (100) DUE TO PAIN, SEVENTY-EIGHT (78) DUE TO PATELLOFEMORAL PAIN, FORTY-SIX (46) DUE TO PATELLA EROSION, FORTY-THREE (43) DUE TO FRACTURE, TWENTY-NINE (29) DUE TO ARTHROFIBROSIS, TEN (10) DUE TO WEAR TIBIAL INSERT, EIGHT (8) DUE TO LYSIS, NINETEEN (19) DUE TO MALALIGNMENT, THIRTEEN (13) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, FIVE (5) DUE TO METAL RELATED PATHOLOGY, SEVEN (7) DUE TO INCORRECT SIZING, SEVEN (7) DUE TO PATELLA MALTRACKING, ELEVEN (11) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, TWO (2) DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO SYNOVITIS, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL, THREE (3) DUE TO WEAR PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE FEMORAL, ONE (1) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO WEAR TIBIAL, SIX (6) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. 3. REVISION TKA PROCEDURES: LEGION REVISION TIBIAL BASEPLATE: IMPLANTED IN ONE THOUSAND FIVE-HUNDRED AND FOURTEEN (1514) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN TWO HUNDRED AND FOUR (204) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIXTY-THREE (63) KNEES DUE TO LOOSENING, FIFTY-NINE (59) DUE TO INFECTION, TWENTY (20) DUE TO INSTABILITY, EIGHTEEN (18) DUE TO PAIN, NINE (9) DUE TO ARTHROFIBROSIS, FOUR (4) DUE TO MALALIGNMENT, FOUR (4) DUE TO PATELLOFEMORAL PAIN, THREE (3) DUE TO PATELLA EROSION, ONE (1) DUE TO LYSIS, FOUR (4) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO METAL RELATED PATHOLOGY, ONE (1) DUE TO WEAR TIBIAL INSERT, ONE (1) DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, TWO (2) DUE TO WEAR PATELLA, FOUR (4) DUE TO OTHER REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH RE-REVISION CASE. LEGION POSTERIOR STABILIZED (PS) OXINIUM FEMORAL COMPONENT: IMPLANTED IN FIFTY-SIX (56) KNEES BETWEEN (B)(6) 2010 AND (B)(6) 2024. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN SIXTEEN (16) CASES DUE TO THE FOLLOWING COMPLICATIONS: THREE (3) KNEES DUE TO ARTHROFIBROSIS, THREE (3) DUE TO INSTABILITY, SEVEN (7) DUE TO LOOSENING, ONE (1) DUE TO PAIN, TWO (2) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR RE-REVISION. LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT: IMPLANTED IN ONE THOUSAND THREE HUNDRED FIFTY-EIGHT (1358) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN ONE HUNDRED AND EIGHTY-EIGHT (188) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTY-EIGHT (58) KNEES DUE TO LOOSENING, FIFTY (50) KNEES DUE TO INFECTION, TWENTY-TWO (22) KNEES DUE TO INSTABILITY, SEVENTEEN (17) KNEES DUE TO PAIN, EIGHT (8) KNEES DUE TO ARTHROFIBROSIS, FOUR (4) KNEES DUE TO MALALIGNMENT, FOUR (4) KNEES DUE TO PATELLOFEMORAL PAIN, TWO (2) KNEES DUE TO PATELLA EROSION, ONE (1) KNEE DUE TO PERIPROSTHETIC FRACTURE, ONE (1) KNEE DUE TO METAL RELATED PATHOLOGY, TWO (2) KNEES DUE TO PATELLA MALTRACKING, NINE (9) KNEES DUE TO BEARING DISLOCATION, ONE (1) KNEE DUE TO WEAR TIBIAL INSERT, ONE (1) KNEE DUE TO IMPLANT BREAKAGE TIBIAL INSERT, ONE (1) KNEE DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) KNEE DUE TO PROSTHESIS DISLOCATION, ONE (1) KNEE DUE TO SYNOVITIS, AND FIVE (5) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH RE-REVISION CASE. ALTOGETHER, A TOTAL QUANTITY OF THREE HUNDRED AND SEVENTY-SIX (376) UKA REVISIONS, FIVE THOUSAND EIGHT HUNDRED AND FIFTY-FOUR (5854) TKA REVISIONS AND FOUR HUNDRED AND EIGHT (408) RE-REVISION TKA SURGERIES, (6638 EVENTS IN TOTAL), HAVE BEEN REPORTED IN THE AOANJRR FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE GENESIS UNI KNEE SYSTEM, JOURNEY II BCS KNEE SYSTEM, THE LEGION TOTAL KNEE SYSTEM, AND THE GENESIS II TOTAL KNEE SYSTEM PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR INDUSTRY SUMMARY REPORTS FOR THE SMITH+NEPHEW PROSTHESES REFERENCED ABOVE WERE REVIEWED FOR THE CORRESPONDING KNEE REPLACEMENT PROCEDURES ANALYZED. POST-OPERATIVE OUTCOMES FOR EACH STUDY DEVICE WERE COMPARED AGAINST THOSE OF THE CLASS, DEFINED AS ALL PROSTHESES UTILIZED IN THE CORRESPONDING PROCEDURE TYPE AS RECORDED BY THE AOANJRR. GENESIS UNI FEMORAL COMPONENTS IN PRIMARY UKA: THIS SYSTEM PERFORMS IN LINE TO ALL OTHER UNICOMPARTMENTAL KNEES AT 1-YEAR BASED ON THE OVERLAPPING 95% CONFIDENCE INTERVAL. FROM 2 THROUGH 15 YEARS OF FOLLOW-UP, GENESIS UNICOMPARTMENTAL KNEE SYSTEM SHOWS HIGHER REVISION RATES COMPARED TO ALL OTHER UNICOMPARTMENTAL KNEES, AS CONFIRMED BY NON-OVERLAPPING CONFIDENCE INTERVALS. FROM 16¿22 YEARS, GENESIS UNICOMPARTMENTAL KNEE SYSTEM PERFORMS IN LINE TO ALL OTHER UNICOMPARTMENTAL KNEES BASED ON THE OVERLAPPING 95% CONFIDENCE INTERVAL. THE REPORTED TRENDS HAVE BEEN PREVIOUSLY OBSERVED IN THE MOST RECENT CLINICAL EVALUATION REPORTS AND CLINICAL EVALUATION MEMOS AND HAVE NOT INCREASED IN SEVERITY. SMITH+NEPHEW WILL CONTINUE TO MONITOR REVISIONS OCCURRING POST-IMPLANTATION. OVERALL, THE GENESIS UNI KNEE SYSTEM LONG-TERM SURVIVORSHIP (7-YEARS AND BEYOND, WHEN ADJUSTED FOR GENDER AND SEX) IS STATISTICALLY IN LINE WITH THE CLASS AVERAGE. JOURNEY II BCS OXINIUM FEMORAL COMPONENTS: THE OVERALL KAPLAN-MEIER CUMULATIVE REVISION RATES FOR THESE DEVICES WERE IN LINE WITH THE AOANJRR CLASS THROUGH 10 YEARS OF FOLLOW-UP, AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS. STRATIFICATION BY PATELLA RESURFACED STATUS SHOWED THAT THE KAPLAN-MEIER CUMULATIVE REVISION RATE IN RESURFACED JOURNEY II BCS TKAS WAS IN LINE WITH THAT OF OTHER TKAS IN THE REGISTRY, AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS, THUS MEETING THE ESTABLISHED BENCHMARK. ON THE CONTRARY, WHEN THE PATELLA WAS NOT RESURFACED THE CUMULATIVE REVISION RATE FOR JOURNEY II BCS OXINIUM WAS SIGNIFICANTLY HIGHER THAN THE CLASS, AS SHOWN BY NON-OVERLAPPING CONFIDENCE INTERVALS. HOWEVER, ONLY 36 JOURNEY II BCS OXINIUM FEMORAL COMPONENTS WERE IMPLANTED WITHOUT PATELLA RESURFACING, THUS THE DATA ARE CONSIDERED NOT TO HAVE SUFFICIENT STATISTICAL POWER TO BE RELIABLE FOR KAPLAN-MEIER SURVIVORSHIP DETERMINATION. THIS IS REFLECTED IN THE WIDE CONFIDENCE INTERVALS OBSERVED. FREQUENCIES FOR REASONS FOR REVISION FOR JOURNEY II OXINIUM WITH RESURFACED PATELLA WERE BELOW OR IN LINE WITH THE CLASS. LEGION TOTAL KNEE SYSTEM IN PRIMARY TKAS: OVERALL LEGION TOTAL KNEE SYSTEM CONSTRUCTS REPORTED SURVIVORSHIP IN LINE WITH THE RESPECTIVE REGISTRY CLASS, AS DETERMINED BY OVERLAPPING CONFIDENCE INTERVALS. ANY STATISTICALLY SIGNIFICANT DIFFERENCE FROM THESE BENCHMARKS CAN BE EXPLAINED AND ATTRIBUTED TO PATELLA RESURFACING, YOUNGER PATIENTS, OR DIFFERENT POPULATIONS SUCH AS USE OF LEGION REVISION COMPONENTS FOR DIFFERENT INDICATIONS WHICH INVOLVE MORE COMPLICATED PRIMARY PROCEDURES AND HIGHER REVISION RATES FOR THE CLASS: A. LEGION PS WITH OXINIUM FEMORAL COMPONENTS USED IN PRIMARY TKA SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. HOWEVER, NUMBER OF YOUNGER PATIENTS (<65 YEARS) IMPLANTED WITH LEGION PS OXINIUM CONSTRUCT (41%) IS HIGHER THAN THE CLASS AVERAGE (32.7%), WHICH THE 2024 AOANJRR ANNUAL REPORT HAS SHOWN TO BE ASSOCIATED WITH HIGHER REVISION RATE. B. LEGION REVISION TIBIAL BASEPLATES SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. THE LEGION REVISION TIBIAL BASEPLATE IS A DEVICE WHICH IS USED IN COMPLEX PRIMARY TKA CASES AND WOULD NOT NORMALLY BE CHOSEN FOR THE MAJORITY OF TKA CASES. DIFFERENCES BETWEEN THE USUAL TKA PATIENTS AND THOSE WITH SEVERE KNEE CONDITIONS REQUIRING A COMPLEX PRIMARY TKA CONTRIBUTE AT LEAST IN PART TO THE HIGHER CUMULATIVE REVISION RATES IN THE PRIMARY TKA POPULATION USING THE LEGION REVISION TIBIAL BASEPLATE. LEGION REVISION TIBIAL BASEPLATE IN PRIMARY TKA WERE USED IN A SMALLER PERCENTAGE FOR OA (87.9%) THAN THE TKA CLASS (97.9%), BUT WERE USED FOR MORE CASES OF RHEUMATOID ARTHRITIS (4.6% VS. 1.1%), OSTEONECROSIS (2.1% VS. 0.3%), TUMOR (0.6% VS. 0.1%), FRACTURE (3.4% VS. 0.1%), AND OTHER (0.8% VS. 0.01%). C. LEGION PS CONSTRAINED INSERTS: LEGION PS WITH CONSTRAINED INSERT SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. IN CONTRAST FROM THE CLASS, LEGION CONSTRAINED INSERTS WERE USED LESS OFTEN FOR THE INDICATION OF OSTEOARTHRITIS (93.6% VS. 97.9%), AND MORE OFTEN FOR THE INDICATIONS OF RHEUMATOID ARTHRITIS (3.3% VS. 1.1.%), FRACTURE (0.9% VS. 0.1%), OSTEONECROSIS (0.7% VS. 0.3%), TUMOUR (0.4% VS. 0.1%) AND ¿OTHER¿ (0.7% VS. 0.01%) INDICATIONS. THESE DIFFERENCES IN INDICATIONS SUGGEST THAT THERE WERE DIFFERENCES IN THE PATIENT POPULATIONS USING CONSTRAINED INSERTS AND THE TKA CLASS. D. LEGION OXINIUM CONSTRAINED FEMORAL COMPONENTS: LEGION CONSTRAINED (REVISION) WITH OXINIUM FEMORAL COMPONENT SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. INDICATIONS FOR PRIMARY TKA SHOW THAT LEGION CONSTRAINED WITH OXINIUM FEMORAL COMPONENT ARE USED IN MORE COMPLEX PRIMARIES (LOWER USAGE FOR OSTEOARTHRITIS 84.2%, AND INCREASED FOR RHEUMATOID ARTHRITIS 5.1%, OSTEONECROSIS 5.1%, FRACTURE 3.5%, AND TUMOR 0.7%) WHEN COMPARED TO THE CLASS (OSTEOARTHRITIS 97.9% RHEUMATOID ARTHRITIS 1.1%, OSTEONECROSIS 0.3%, FRACTURE AND TUMOR 0.1% EACH). DIFFERENCES BETWEEN THE USUAL TKA PATIENTS AND THOSE WITH SEVERE KNEE CONDITIONS REQUIRING A COMPLEX PRIMARY TKA CONTRIBUTE AT LEAST IN PART TO THE HIGHER CUMULATIVE REVISION RATES IN THE PRIMARY TKA POPULATION. LEGION TOTAL KNEE SYSTEM IN REVISION TKAS: THE LEGION TOTAL KNEE SYSTEM CONSTRUCTS REPORTED SURVIVORSHIP IN LINE WITH THE RESPECTIVE REGISTRY CLASS, AS DETERMINED BY OVERLAPPING CONFIDENCE INTERVALS. ONLY THE LEGION PS KNEES WITH OXINIUM MATERIAL SHOWED CUMULATIVE REVISION RATES THAT ARE HIGHER THAN THE TKA CLASS AVERAGE AS DETERMINED BY NON-OVERLAPPING CONFIDENCE INTERVALS. THE LEGION PS OXINIUM FEMORAL COMPONENTS HAVE BEEN USED UN 56 REVISION TKAS AND THE NUMBER AT RISK IS BELOW 30 KNEES AT 4 YEARS (29) AND DROPS TO ONLY 11 KNEES AT 10 YEARS, MAKING THE REVISION RATES LESS ACCURATE AND THE CONFIDENCE INTERVALS AT ALL TIME PERIODS WIDE. DIFFERENCES IN POPULATIONS FROM THE CLASS INCLUDE A HIGHER PERCENTAGE OF PATIENTS YOUNGER THAN 65 YEARS OLD (50% FOR LEGION PS OXINIUM VS. 31% FOR THE CLASS). THE 2024 AOANJRR ANNUAL REPORT REPORTS YOUNGER AGE TO BE ASSOCIATED WITH HIGHER REVISION RATE. GENESIS II TOTAL KNEE SYSTEM: OVERALL, GENESIS II TOTAL KNEE SYSTEM CONSTRUCTS REPORTED SURVIVORSHIP IN LINE WITH THE RESPECTIVE REGISTRY CLASS, AS DETERMINED BY OVERLAPPING CONFIDENCE INTERVALS. A. GENESIS II NON-POROUS CR COCR FEMORAL COMPONENT IN PRIMARY TKA: ACCORDING TO OVERLAPPING 95% CONFIDENCE INTERVALS DURING THE 23 YEARS OF FOLLOW-UP, THERE IS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN CUMULATIVE REVISION RATES BETWEEN GENESIS II NON-POROUS CR COCR FEMORAL COMPONENT AND THE CLASS. THEREFORE, GENESIS II NON-POROUS CR COCR FEMORAL COMPONENT MET THE ANTICIPATED SURVIVORSHIP IN THE AOANJRR. B. GENESIS II PS NON-POROUS COCR FEMORAL COMPONENT IN PRIMARY TKA: CUMULATIVE REVISION RATES FOR THE GENESIS II PS NON-POROUS COCR FEMORAL COMPONENT ARE ALIGNED WITH THE CLASS AVERAGE DURING THE 23 YEARS OF FOLLOW-UP, BASED ON OVERLAPPING 95% CONFIDENCE INTERVALS. THEREFORE, THE GENESIS II PS NON-POROUS COCR FEMORAL COMPONENT MET THE ANTICIPATED SURVIVORSHIP IN THE AOANJRR. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE AND PROCEDURE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 2 (APRIL 1 - JUN 30, 2025) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY UKA PROCEDURES: GENESIS UNI FEMORAL COMPONENTS: IMPLANTED IN TWO THOUSAND ONE HUNDRED AND NINETY-EIGHT (2,198) KNEES BETWEEN 15-NOV-1999 AND 03-FEB-2014. THESE INCLUDE SIZE VARIANTS CERTIFIED FOR USE IN THE UNITED STATES UNDER PRO CODES HSX, JWH AND JDI. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FIVE HUNDRED SIX (506) CASES DUE TO THE FOLLOWING COMPLICATIONS: ONE HUNDRED AND EIGHTY-SEVEN (187) KNEES DUE TO PROGRESSION OF DISEASE, TWO HUNDRED AND EIGHTEEN (218) KNEES DUE TO LOOSENING, THIRTY (30) KNEES DUE TO PAIN, TWELVE (12) KNEES DUE TO INFECTION, FOURTEEN (14) KNEES DUE TO LYSIS, THREE (3) KNEES DUE TO FRACTURE, NINE (9) KNEES DUE TO WEAR OF TIBIAL INSERT, FIVE (5) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO MALALIGNMENT, FIVE (5) KNEES DUE TO IMPLANT BREAKAGE ASSOCIATED WITH THE TIBIAL COMPONENT, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, FOUR (4) KNEES DUE TO TIBIAL WEAR, TWO (2) KNEES DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO INCORRECT SIZING, FIVE (5) KNEES DUE TO OSTEONECROSIS, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO PATELLA EROSION AND TWO (2) KNEES DUE TO OTHER-UNSPECIFIED REASONS. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 506 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE JWH. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 506 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 376 REVISIONS ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS UNI FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE JWH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 376 CASES. 2. PRIMARY TKA PROCEDURES: JOURNEY II BCS OXINIUM FEMORAL COMPONENTS: IMPLANTED IN FOUR THOUSAND FIVE HUNDRED AND TWENTY-FIVE (4,525) KNEES BETWEEN 26-AUG-13 AND 30-APR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FORTY-FOUR (44) CASES DUE TO THE FOLLOWING COMPLICATIONS: NINETEEN (19) KNEES DUE TO INFECTION, SIX (6) KNEES DUE TO INSTABILITY, FOUR (4) KNEES DUE TO LOOSENING, FOUR (4) KNEES DUE TO PAIN, FOUR (4) KNEES DUE TO FRACTURE, TWO (2) KNEES DUE TO PATELLA EROSION, ONE (1) KNEE DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO WEAR OF THE TIBIAL INSERT, AND ONE (1) KNEE DUE TO SYNOVITIS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. LEGION TOTAL KNEE SYSTEM POROUS TIBIAL BASEPLATES WITHOUT HOLES: IMPLANTED IN FOUR HUNDRED AND SIXTY-EIGHT (468) KNEES BETWEEN 16-AUG-2018 AND 27-FEB-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SIX (6) CASES DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) DUE TO INFECTION, THREE (3) DUE TO LOOSENING, ONE (1) DUE TO PAIN, AND ONE (1) DUE TO PATELLA MALTRACKING. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. LEGION CRUCIATE RETAINING (CR) COBALT-CHROMIUM (COCR) NON-POROUS FEMORAL COMPONENTS (STANDARD AND NARROW): IMPLANTED IN FIVE THOUSAND THREE-HUNDRED AND FIFTEEN (5,315) KNEES BETWEEN 19-MAY-2006 AND 07-MAR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN ONE HUNDRED AND FIFTY (150) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTY-SEVEN (57) HIPS DUE TO INFECTION, TWENTY-ONE (21) DUE TO LOOSENING, THIRTEEN (13) DUE TO INSTABILITY, TWELVE (12) DUE TO PAIN, SEVEN (7) DUE TO PATELLOFEMORAL PAIN, SIXTEEN (16) DUE TO PATELLA EROSION, ONE (1) DUE TO FRACTURE, SIX (6) DUE TO ARTHROFIBROSIS, THREE (3) DUE TO LYSIS, FOUR (4) DUE TO MALALIGNMENT, ONE (1) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO PROSTHESIS DISLOCATION, FIVE (5) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION POSTERIOR STABILIZED (PS) COBALT-CHROMIUM (COCR) NON-POROUS FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN SIX THOUSAND SIX-HUNDRED AND EIGHTY-EIGHT (6,688) KNEES BETWEEN 14-MAY-2008 AND 27-FEB-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWO-HUNDRED AND FORTY-THREE (243) CASES DUE TO THE FOLLOWING COMPLICATIONS: A HUNDRED AND SEVEN (107) KNEES DUE TO INFECTION, FIFTY-ONE (51) DUE TO LOOSENING, SEVENTEEN (17) DUE TO INSTABILITY, EIGHT (8) DUE TO PAIN, FOUR (4) DUE TO PATELLOFEMORAL PAIN, SIX (6) DUE TO PATELLA EROSION, FIFTEEN (15) DUE TO FRACTURE, ELEVEN (11) DUE TO ARTHROFIBROSIS, EIGHT (8) DUE TO MALALIGNMENT, ONE (1) DUE TO METAL RELATED PATHOLOGY, THREE (3) DUE TO INCORRECT SIZING, TWO (2) DUE TO PATELLA MALTRACKING, THREE (3) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO WEAR PATELLA, FIVE (5) DUE TO OTHER CAUSES. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION CRUCIATE RETAINING (CR) OXINIUM FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN THIRTEEN THOUSAND AND NINETY-ONE (13,091) KNEES BETWEEN 13-SEP-2006 AND 07-MAR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN THREE HUNDRED AND EIGHTY-ONE (381) CASES DUE TO THE FOLLOWING COMPLICATIONS: EIGHTY-SEVEN (87) KNEES DUE TO INFECTION, SEVENTY-TWO (72) DUE TO LOOSENING, FIFTY-EIGHT (58) DUE TO INSTABILITY, THIRTY-SIX (36) DUE TO PAIN, FOURTEEN (14) DUE TO PATELLOFEMORAL PAIN, FORTY-EIGHT (48) DUE TO PATELLA EROSION, TWELVE (12) DUE TO FRACTURE, TWENTY-FIVE (25) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO WEAR TIBIAL INSERT, TEN (10) DUE TO MALALIGNMENT, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, FIVE (5) DUE TO INCORRECT SIZING, FOUR (4) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL, ONE (1) DUE TO WEAR PATELLA, TWO (2) DUE TO OSTEONECROSIS, TWO (2) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION POSTERIOR STABILIZED (PS) OXINIUM FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN TWENTY THOUSAND AND FIFTY-FOUR (20,054) KNEES BETWEEN 01-JUN-2006 AND 10-MAR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN EIGHT HUNDRED AND FIFTY (850) CASES DUE TO THE FOLLOWING COMPLICATIONS: TWO HUNDRED THREE (203) KNEES DUE TO INFECTION, ONE HUNDRED SEVENTY-FIVE (175) DUE TO LOOSENING, ONE HUNDRED ONE (101) DUE TO INSTABILITY, SIXTY-ONE (61) DUE TO PAIN, FIFTY-FOUR (54) DUE TO PATELLOFEMORAL PAIN, FORTY-SEVEN (47) DUE TO PATELLA EROSION, THIRTY-SEVEN (37) DUE TO FRACTURE, FORTY-EIGHT (48) DUE TO ARTHROFIBROSIS, TEN (10) DUE TO WEAR TIBIAL INSERT, SEVEN (7) DUE TO LYSIS, NINETEEN (19) DUE TO MALALIGNMENT, FORTY-ONE (41) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, SIX (6) DUE TO INCORRECT SIZING, SIX (6) DUE TO PATELLA MALTRACKING, TEN (10) DUE TO BEARING DISLOCATION, SIX (6) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO SYNOVITIS, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL, ONE (1) DUE TO WEAR PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE FEMORAL, FIVE (5) DUE TO OSTEONECROSIS, ONE (1) DUE TO HETEROTOPIC BONE, NINE (9) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION REVISION TIBIAL BASEPLATE: IMPLANTED IN NINE HUNDRED SEVENTY-EIGHT (978) KNEES BETWEEN 16-MAY-2006 AND 28-JAN-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SEVENTY-EIGHT (78) CASES DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-FOUR (34) KNEES DUE TO INFECTION, TEN (10) DUE TO LOOSENING, EIGHT (8) DUE TO INSTABILITY, FIVE (5) DUE TO PAIN, TWO (2) DUE TO PATELLOFEMORAL PAIN, TWO (2) DUE TO PATELLA EROSION, FIVE (5) DUE TO FRACTURE, TWO (2) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO PATELLA MALTRACKING, SEVEN (7) DUE TO BEARING DISLOCATION, ONE (1) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL TIBIAL BASEPLATES PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION POSTERIOR STABILIZED (PS) OR CRUCIATE RETAINING (CR) HIGH FLEX INSERTS: IMPLANTED IN SIXTY-TWO THOUSAND FOUR HUNDRED AND THIRTY-ONE (62,431) KNEES BETWEEN 08-APR-2010 AND 04-APR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWO THOUSAND AND SEVENTY-SIX (2,176) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIX HUNDRED NINETEEN (619) KNEES DUE TO INFECTION, FOUR HUNDRED TWENTY-ONE (421) DUE TO LOOSENING, ONE HUNDRED EIGHTY (180) DUE TO INSTABILITY, ONE HUNDRED SEVENTY-THREE (173) DUE TO PAIN, NINETY-SEVEN (97) DUE TO PATELLOFEMORAL PAIN, ONE HUNDRED SIXTY-NINE (169) DUE TO PATELLA EROSION, SEVENTY-NINE (79) DUE TO FRACTURE, ONE HUNDRED FORTY-SEVEN (147) DUE TO ARTHROFIBROSIS, FIFTY-THREE (53) DUE TO MALALIGNMENT, FOURTEEN (14) DUE TO LYSIS, FOURTEEN (14) DUE TO WEAR TIBIAL INSERT, FOUR (4) DUE TO METAL RELATED PATHOLOGY, TWENTY-SEVEN (27) DUE TO INCORRECT SIZING, FIFTY-FOUR (54) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, TWENTY-TWO (22) DUE TO PATELLA MALTRACKING, EIGHTEEN (18) DUE TO BEARING DISLOCATION, TWELVE (12) DUE TO IMPLANT BREAKAGE PATELLA, FOUR (4) DUE TO PROSTHESIS DISLOCATION, SEVEN (7) DUE TO SYNOVITIS, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL, NINE (9) DUE TO WEAR PATELLA, NINE (9) DUE TO OSTEONECROSIS, FOUR (4) DUE TO IMPLANT BREAKAGE FEMORAL, FOUR (4) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO PROGRESSION OF DISEASE, THIRTY-THREE (33) DUE TO OTHER-UNSPECIFIED REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION CONSTRAINED ARTICULAR INSERT: IMPLANTED IN FOUR HUNDRED AND FIFTY (450) KNEES BETWEEN 12-JAN-2007 AND 28-JAN-25. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN THIRTY-SEVEN (37) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTEEN (15) KNEES DUE TO INFECTION, FIVE (5) DUE TO LOOSENING, FIVE (5) DUE TO INSTABILITY, FOUR (4) DUE TO PAIN, ONE (1) DUE TO PATELLOFEMORAL PAIN, ONE (1) DUE TO PATELLA EROSION, ONE (1) DUE TO FRACTURE, ONE (1) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO PATELLA MALTRACKING, THREE (3) DUE TO BEARING DISLOCATION. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION CRUCIATE RETAINING (CR) DEEP-DISH XLPE INSERT: IMPLANTED IN THREE THOUSAND EIGHT-HUNDRED AND SIX (3,806) KNEES BETWEEN 24-JUL-2018 AND 27-FEB-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SEVENTY-EIGHT (78) CASES DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-ONE (31) KNEES DUE TO INFECTION, TWELVE (12) DUE TO LOOSENING, SIX (6) DUE TO INSTABILITY, FIVE (5) DUE TO PAIN, SEVEN (7) DUE TO PATELLA EROSION, SEVEN (7) DUE TO ARTHROFIBROSIS, TWO (2) DUE TO FRACTURE, TWO (2) DUE TO MALALIGNMENT, TWO (2) DUE TO INCORRECT SIZING, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, TWO (2) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO WEAR PATELLA. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT: IMPLANTED IN FIVE HUNDRED FORTY-SIX (546) KNEES BETWEEN 25-MAY-2006 AND 28-JAN-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FORTY-EIGHT (48) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIXTEEN (16) KNEES DUE TO INFECTION, EIGHT (8) KNEES DUE TO LOOSENING, FOUR (4) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO PAIN, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO PATELLA EROSION, THREE (3) KNEES DUE TO PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO PATELLA MALTRACKING, AND FIVE (5) KNEES DUE TO BEARING DISLOCATION. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. 3. REVISION TKA PROCEDURES: - LEGION REVISION TIBIAL BASEPLATE: IMPLANTED IN ONE THOUSAND FIVE-HUNDRED AND FOURTEEN (1514) KNEES BETWEEN 23-MAY-2006 AND 11-FEB-2025. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN TWO HUNDRED AND FOUR (204) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIXTY-THREE (63) KNEES DUE TO LOOSENING, FIFTY-NINE (59) DUE TO INFECTION, TWENTY (20) DUE TO INSTABILITY, EIGHTEEN (18) DUE TO PAIN, NINE (9) DUE TO ARTHROFIBROSIS, FOUR (4) DUE TO MALALIGNMENT, FOUR (4) DUE TO PATELLOFEMORAL PAIN, THREE (3) DUE TO PATELLA EROSION, ONE (1) DUE TO LYSIS, FOUR (4) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO METAL RELATED PATHOLOGY, ONE (1) DUE TO WEAR TIBIAL INSERT, ONE (1) DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, TWO (2) DUE TO WEAR PATELLA, FOUR (4) DUE TO OTHER REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH RE-REVISION CASE. - LEGION POSTERIOR STABILIZED (PS) OXINIUM FEMORAL COMPONENT: IMPLANTED IN FIFTY-SIX (56) KNEES BETWEEN 02-DEC-2010 AND 18-DEC-2024. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN SIXTEEN (16) CASES DUE TO THE FOLLOWING COMPLICATIONS: THREE (3) KNEES DUE TO ARTHROFIBROSIS, THREE (3) DUE TO INSTABILITY, SEVEN (7) DUE TO LOOSENING, ONE (1) DUE TO PAIN, TWO (2) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR RE-REVISION. - LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT: IMPLANTED IN ONE THOUSAND THREE HUNDRED FIFTY-EIGHT (1358) KNEES BETWEEN 6-JUN-2006 AND 11-FEB-2025. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN ONE HUNDRED AND EIGHTY-EIGHT (188) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTY-EIGHT (58) KNEES DUE TO LOOSENING, FIFTY (50) KNEES DUE TO INFECTION, TWENTY-TWO (22) KNEES DUE TO INSTABILITY, SEVENTEEN (17) KNEES DUE TO PAIN, EIGHT (8) KNEES DUE TO ARTHROFIBROSIS, FOUR (4) KNEES DUE TO MALALIGNMENT, FOUR (4) KNEES DUE TO PATELLOFEMORAL PAIN, TWO (2) KNEES DUE TO PATELLA EROSION, ONE (1) KNEE DUE TO PERIPROSTHETIC FRACTURE, ONE (1) KNEE DUE TO METAL RELATED PATHOLOGY, TWO (2) KNEES DUE TO PATELLA MALTRACKING, NINE (9) KNEES DUE TO BEARING DISLOCATION, ONE (1) KNEE DUE TO WEAR TIBIAL INSERT, ONE (1) KNEE DUE TO IMPLANT BREAKAGE TIBIAL INSERT, ONE (1) KNEE DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) KNEE DUE TO PROSTHESIS DISLOCATION, ONE (1) KNEE DUE TO SYNOVITIS, AND FIVE (5) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH RE-REVISION CASE. ALTOGETHER, A TOTAL QUANTITY OF THREE HUNDRED AND SEVENTY-SIX (376) UKA REVISION SURGERIES, FOUR THOUSAND AND NINETY-ONE (4,091) TKA REVISION SURGERIES AND FOUR HUNDRED AND EIGHT (408) RE-REVISION SURGERIES HAVE BEEN REPORTED IN THE AOANJRR FOR THE SMITH+NEPHEW DEVICES REFERENCED ABOVE. THIS RESULTS IN A CUMULATIVE TOTAL OF FOUR THOUSAND EIGHT HUNDRED AND SEVENTY-FIVE (4,875) EVENTS SUMMARIZED IN THE CURRENT 3500A FORM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE GENESIS UNI KNEE SYSTEM, JOURNEY II BCS KNEE SYSTEM AND THE LEGION TOTAL KNEE SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AN AOANJRR INDUSTRY REPORT WAS REVIEWED FOR THE GENESIS UNI FEMORAL COMPONENTS IN PRIMARY UNICOMPARTMENTAL KNEE REPLACEMENT PROCEDURES. THIS SYSTEM PERFORMS IN LINE TO ALL OTHER UNICOMPARTMENTAL KNEES AT 1-YEAR BASED ON THE OVERLAPPING 95% CONFIDENCE INTERVAL. FROM 2 THROUGH 15 YEARS OF FOLLOW-UP, GENESIS UNICOMPARTMENTAL KNEE SYSTEM SHOWS HIGHER REVISION RATES COMPARED TO ALL OTHER UNICOMPARTMENTAL KNEES, AS CONFIRMED BY NON-OVERLAPPING CONFIDENCE INTERVALS. FROM 16¿22 YEARS, GENESIS UNICOMPARTMENTAL KNEE SYSTEM PERFORMS IN LINE TO ALL OTHER UNICOMPARTMENTAL KNEES BASED ON THE OVERLAPPING 95% CONFIDENCE INTERVAL. THE REPORTED TRENDS HAVE BEEN PREVIOUSLY OBSERVED IN THE MOST RECENT CLINICAL EVALUATION REPORTS AND CLINICAL EVALUATION MEMOS AND HAVE NOT INCREASED IN SEVERITY. SMITH+NEPHEW WILL CONTINUE TO MONITOR REVISIONS OCCURRING POST-IMPLANTATION. OVERALL, THE GENESIS UNI KNEE SYSTEM LONG-TERM SURVIVORSHIP (7-YEARS AND BEYOND, WHEN ADJUSTED FOR GENDER AND SEX) IS STATISTICALLY IN LINE WITH THE CLASS AVERAGE. REGARDING THE JOURNEY II BCS OXINIUM FEMORAL COMPONENTS, A SPECIFIC AOANJRR INDUSTRY REPORT WAS REVIEWED AND REVEALED THAT THE OVERALL KAPLAN-MEIER CUMULATIVE REVISION RATES FOR THESE DEVICES WERE IN LINE WITH THE AOANJRR CLASS THROUGH 10 YEARS OF FOLLOW-UP, AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS. STRATIFICATION BY PATELLA RESURFACED STATUS SHOWED THAT THE KAPLAN-MEIER CUMULATIVE REVISION RATE IN RESURFACED JOURNEY II BCS TKAS WAS IN LINE WITH THAT OF OTHER TKAS IN THE REGISTRY, AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS, THUS MEETING THE ESTABLISHED BENCHMARK. ON THE CONTRARY, WHEN THE PATELLA WAS NOT RESURFACED THE CUMULATIVE REVISION RATE FOR JOURNEY II BCS OXINIUM WAS SIGNIFICANTLY HIGHER THAN THE CLASS, AS SHOWN BY NON-OVERLAPPING CONFIDENCE INTERVALS. HOWEVER, ONLY 36 JOURNEY II BCS OXINIUM FEMORALS WERE IMPLANTED WITHOUT PATELLA RESURFACING, THUS THE DATA ARE CONSIDERED NOT TO HAVE SUFFICIENT STATISTICAL POWER TO BE RELIABLE FOR KAPLAN-MEIER SURVIVORSHIP DETERMINATION. THIS IS REFLECTED IN THE WIDE CONFIDENCE INTERVALS OBSERVED. FREQUENCIES FOR REASONS FOR REVISION FOR JOURNEY II OXINIUM WITH RESURFACED PATELLA WERE BELOW OR IN LINE WITH THE CLASS. LASTLY, SEVERAL AOANJRR INDUSTRY REPORTS WERE OBTAINED TO REVIEW THE PERFORMANCE OF SEVERAL LEGION TOTAL KNEE SYSTEM IMPLANTS USED IN PRIMARY TKAS. OVERALL LEGION TOTAL KNEE SYSTEM CONSTRUCTS REPORTED SURVIVORSHIP IN LINE WITH THE RESPECTIVE REGISTRY CLASS, AS DETERMINED BY OVERLAPPING CONFIDENCE INTERVALS. ANY STATISTICALLY SIGNIFICANT DIFFERENCE FROM THESE BENCHMARKS CAN BE EXPLAINED AND ATTRIBUTED TO PATELLA RESURFACING, YOUNGER PATIENTS, OR DIFFERENT POPULATIONS SUCH AS USE OF LEGION REVISION COMPONENTS FOR DIFFERENT INDICATIONS WHICH INVOLVE MORE COMPLICATED PRIMARY PROCEDURES AND HIGHER REVISION RATES FOR THE CLASS: A. LEGION PS WITH OXINIUM FEMORAL COMPONENTS USED IN PRIMARY TKA SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. HOWEVER, NUMBER OF YOUNGER PATIENTS (<65 YEARS) IMPLANTED WITH LEGION PS OXINIUM CONSTRUCT (41%) IS HIGHER THAN THE CLASS AVERAGE (32.7%), WHICH THE 2024 AOANJRR ANNUAL REPORT HAS SHOWN TO BE ASSOCIATED WITH HIGHER REVISION RATE. B. LEGION REVISION TIBIAL BASEPLATES SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. THE LEGION REVISION TIBIAL BASEPLATE IS A DEVICE WHICH IS USED IN COMPLEX PRIMARY TKA CASES AND WOULD NOT NORMALLY BE CHOSEN FOR THE MAJORITY OF TKA CASES. DIFFERENCES BETWEEN THE USUAL TKA PATIENTS AND THOSE WITH SEVERE KNEE CONDITIONS REQUIRING A COMPLEX PRIMARY TKA CONTRIBUTE AT LEAST IN PART TO THE HIGHER CUMULATIVE REVISION RATES IN THE PRIMARY TKA POPULATION USING THE LEGION REVISION TIBIAL BASEPLATE. LEGION REVISION TIBIAL BASEPLATE IN PRIMARY TKA WERE USED IN A SMALLER PERCENTAGE FOR OA (87.9%) THAN THE TKA CLASS (97.9%), BUT WERE USED FOR MORE CASES OF RHEUMATOID ARTHRITIS (4.6% VS. 1.1%), OSTEONECROSIS (2.1% VS. 0.3%), TUMOR (0.6% VS. 0.1%), FRACTURE (3.4% VS. 0.1%), AND OTHER (0.8% VS. 0.01%). C. LEGION PS CONSTRAINED INSERTS: LEGION PS WITH CONSTRAINED INSERT SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. IN CONTRAST FROM THE CLASS, LEGION CONSTRAINED INSERTS WERE USED LESS OFTEN FOR THE INDICATION OF OSTEOARTHRITIS (93.6% VS. 97.9%), AND MORE OFTEN FOR THE INDICATIONS OF RHEUMATOID ARTHRITIS (3.3% VS. 1.1.%), FRACTURE (0.9% VS. 0.1%), OSTEONECROSIS (0.7% VS. 0.3%), TUMOUR (0.4% VS. 0.1%) AND ¿OTHER¿ (0.7% VS. 0.01%) INDICATIONS. THESE DIFFERENCES IN INDICATIONS SUGGEST THAT THERE WERE DIFFERENCES IN THE PATIENT POPULATIONS USING CONSTRAINED INSERTS AND THE TKA CLASS. D. LEGION OXINIUM CONSTRAINED FEMORAL COMPONENTS: LEGION CONSTRAINED (REVISION) WITH OXINIUM FEMORAL COMPONENT SHOWED HIGHER CUMULATIVE REVISION RATE THAN THE CLASS AVERAGE. INDICATIONS FOR PRIMARY TKA SHOW THAT LEGION CONSTRAINED WITH OXINIUM FEMORAL COMPONENT ARE USED IN MORE COMPLEX PRIMARIES (LOWER USAGE FOR OSTEOARTHRITIS 84.2%, AND INCREASED FOR RHEUMATOID ARTHRITIS 5.1%, OSTEONECROSIS 5.1%, FRACTURE 3.5%, AND TUMOR 0.7%) WHEN COMPARED TO THE CLASS (OSTEOARTHRITIS 97.9% RHEUMATOID ARTHRITIS 1.1%, OSTEONECROSIS 0.3%, FRACTURE AND TUMOR 0.1% EACH). DIFFERENCES BETWEEN THE USUAL TKA PATIENTS AND THOSE WITH SEVERE KNEE CONDITIONS REQUIRING A COMPLEX PRIMARY TKA CONTRIBUTE AT LEAST IN PART TO THE HIGHER CUMULATIVE REVISION RATES IN THE PRIMARY TKA POPULATION. REGARDING THE PERFORMANCE OF LEGION TOTAL KNEE SYSTEM IMPLANTS USED IN REVISION TKA, THE LEGION TOTAL KNEE SYSTEM CONSTRUCTS REPORTED SURVIVORSHIP IN LINE WITH THE RESPECTIVE REGISTRY CLASS, AS DETERMINED BY OVERLAPPING CONFIDENCE INTERVALS. ONLY THE LEGION PS KNEES WITH OXINIUM MATERIAL SHOWED CUMULATIVE REVISION RATES THAT ARE HIGHER THAN THE TKA CLASS AVERAGE AS DETERMINED BY NON-OVERLAPPING CONFIDENCE INTERVALS. THE LEGION PS OXINIUM FEMORAL COMPONENTS HAVE BEEN USED UN 56 REVISION TKAS AND THE NUMBER AT RISK IS BELOW 30 KNEES AT 4 YEARS (29) AND DROPS TO ONLY 11 KNEES AT 10 YEARS, MAKING THE REVISION RATES LESS ACCURATE AND THE CONFIDENCE INTERVALS AT ALL TIME PERIODS WIDE. DIFFERENCES IN POPULATIONS FROM THE CLASS INCLUDE A HIGHER PERCENTAGE OF PATIENTS YOUNGER THAN 65 YEARS OLD (50% FOR LEGION PS OXINIUM VS. 31% FOR THE CLASS). THE 2024 AOANJRR ANNUAL REPORT REPORTS YOUNGER AGE TO BE ASSOCIATED WITH HIGHER REVISION RATE. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE AND PROCEDURE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem · 0

asty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-530,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-531,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-532,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-533,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-534,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-535,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-536,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-537,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-538,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-539,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-540,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-541,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-542,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-543,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-544,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-545,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-546,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-547,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-548,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-549,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-550,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-551,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-552,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-553,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-554,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-555,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-556,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-557,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-558,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-559,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-560,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-561,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-562,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-563,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-564,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-565,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-566,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-567,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-568,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-569,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-570,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-571,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-572,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-573,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-574,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-575,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-576,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-577,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-578,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-579,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-580,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-581,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-582,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-583,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-584,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-585,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-586,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-587,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-588,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-589,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-590,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-591,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-592,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-593,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-594,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-595,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-596,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-597,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-598,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-599,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-600,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-601,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-602,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-603,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-604,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-605,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-606,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-607,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-608,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-609,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-610,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-611,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-612,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-613,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-614,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-615,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-616,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-617,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-618,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-619,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-620,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-621,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-622,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-623,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-624,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-625,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-626,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-627,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-628,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-629,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-630,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-631,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-632,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-633,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-634,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-635,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-636,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-637,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-638,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-639,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-640,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-641,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-642,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-643,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-644,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-645,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-646,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-647,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-648,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-649,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-650,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-651,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-652,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-653,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-654,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-655,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-656,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-657,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-658,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-659,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-660,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-661,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-662,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-663,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-664,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-665,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-666,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-667,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-668,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-669,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-670,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-671,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-672,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-673,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-674,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-675,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-676,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-677,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-678,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-679,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-680,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-681,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-682,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-683,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-684,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-685,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-686,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-687,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-688,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-689,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-690,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-691,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-692,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-693,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-694,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-695,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-696,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-697,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-698,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-699,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-700,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-701,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-702,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-703,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-704,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-705,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-706,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-707,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-708,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-709,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-710,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-711,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-712,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-713,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-714,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-715,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-716,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-717,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-718,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-719,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-720,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-721,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-722,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-723,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-724,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-725,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-726,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-727,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-728,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-729,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-730,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-731,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-732,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-733,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-734,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-735,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-736,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-737,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-738,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-739,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-740,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-741,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-742,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-743,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-744,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-745,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-746,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-747,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-748,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-749,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-750,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-751,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-752,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-753,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-754,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-755,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-756,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-757,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-758,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-759,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-760,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-761,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-762,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-763,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-764,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-765,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-766,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-767,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-768,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-769,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-770,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-771,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-772,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-773,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-774,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-775,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-776,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-777,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-778,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-779,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-780,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-781,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-782,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-783,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-784,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-785,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-786,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-787,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-788,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-789,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-790,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-791,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-792,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-793,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-794,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-795,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-796,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-797,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-798,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-799,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-800,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-801,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-802,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-803,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-804,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-805,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-806,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-807,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-808,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-809,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-810,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-811,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-812,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-813,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-814,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-815,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-816,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-817,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-818,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-819,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-820,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-821,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-822,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-823,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-824,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-825,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-826,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-827,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-828,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-829,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-830,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-831,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-832,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-833,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-834,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-835,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-836,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-837,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-838,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-839,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-840,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-841,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-842,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-843,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-844,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-845,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-846,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-847,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-848,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-849,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-850,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-851,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-852,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-853,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-854,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-855,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-856,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-857,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-858,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-859,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-860,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-861,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-862,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-863,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-864,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-865,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-866,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-867,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-868,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-869,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-870,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-871,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-872,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-873,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-874,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-875,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-876,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-877,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-878,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-879,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-880,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-881,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-882,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-883,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-884,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-885,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-886,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-887,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-888,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-889,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-890,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-891,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-892,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-893,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-894,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-895,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-896,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-897,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-898,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-899,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-900,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-901,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-902,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-903,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-904,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-905,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-906,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-907,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-908,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-909,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-910,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-911,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-912,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-913,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-914,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-915,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-916,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-917,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-918,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-919,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-920,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-921,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-922,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-923,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-924,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-925,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-926,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-927,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-928,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-929,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-930,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-931,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-932,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-933,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-934,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-935,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-936,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-937,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-938,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-939,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-940,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-941,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-942,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-943,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-944,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-945,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-946,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-947,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-948,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-949,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-950,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-951,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-952,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-953,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-954,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-955,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-956,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-957,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-958,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-959,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-960,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-961,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-962,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-963,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-964,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-965,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-966,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-967,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-968,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-969,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-970,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-971,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-972,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-973,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-974,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-975,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-976,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-977,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-978,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-979,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-980,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-981,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-982,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-983,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-984,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-985,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-986,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-987,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-988,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-989,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-990,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-991,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-992,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-993,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-994,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-995,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-996,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-997,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-998,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-999,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1000,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1001,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1002,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1003,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1004,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1005,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1006,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1007,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1008,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1009,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1010,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1011,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1012,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1013,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1014,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1015,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1016,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1017,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1018,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1019,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1020,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1021,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1022,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1023,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1024,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1025,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1026,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1027,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1028,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1029,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1030,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1031,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1032,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1033,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1034,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1035,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1036,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1037,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1038,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1039,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1040,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1041,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1042,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1043,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1044,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1045,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1046,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1047,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1048,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1049,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1050,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1051,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1052,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1053,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1054,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1055,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1056,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1057,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1058,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1059,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1060,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1061,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1062,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1063,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1064,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1065,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1066,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1067,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1068,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1069,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1070,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1071,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1072,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1073,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1074,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1075,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1076,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1077,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1078,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1079,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1080,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1081,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1082,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1083,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1084,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1085,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1086,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1087,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1088,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1089,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1090,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1091,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1092,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1093,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1094,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1095,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1096,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1097,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1098,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1099,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1100,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1101,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1102,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1103,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1104,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1105,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1106,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1107,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1108,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1109,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1110,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1111,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1112,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1113,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1114,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1115,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1116,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1117,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1118,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1119,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1120,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1121,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1122,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1123,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1124,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1125,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1126,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1127,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1128,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1129,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1130,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1131,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1132,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1133,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1134,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1135,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1136,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1137,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1138,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1139,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1140,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1141,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1142,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1143,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1144,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1145,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1146,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1147,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1148,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1149,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1150,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1151,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1152,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1153,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1154,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1155,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1156,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1157,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1158,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1159,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1160,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1161,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1162,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1163,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1164,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1165,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1166,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1167,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1168,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1169,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1170,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1171,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1172,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1173,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1174,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1175,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1176,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1177,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1178,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1179,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1180,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1181,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1182,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1183,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1184,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1185,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1186,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1187,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1188,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1189,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1190,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1191,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1192,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1193,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1194,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1195,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1196,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1197,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1198,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1199,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1200,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1201,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1202,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1203,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1204,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 6,71421016,,71421016,,03596010469229,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1205,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1206,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1207,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1208,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1209,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1210,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1211,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1212,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1213,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1214,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1215,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1216,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1217,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1218,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1219,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1220,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1221,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1222,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1223,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1224,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1225,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1226,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1227,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1228,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1229,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1230,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1231,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1232,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1233,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1234,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1235,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1236,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1237,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1238,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1239,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1240,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1241,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1242,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1243,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1244,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1245,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1246,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1247,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1248,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1249,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1250,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1251,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1252,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1253,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1254,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1255,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1256,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1257,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1258,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1259,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1260,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1261,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1262,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1263,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1264,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1265,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1266,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1267,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1268,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1269,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1270,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1271,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1272,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1273,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1274,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1275,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1276,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1277,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1278,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1279,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1280,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1281,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1282,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1283,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1284,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1285,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1286,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1287,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1288,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1289,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1290,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1291,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1292,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1293,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1294,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1295,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1296,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1297,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1298,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1299,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1300,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1301,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1302,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1303,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1304,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1305,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1306,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1307,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1308,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1309,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1310,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1311,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1312,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1313,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1314,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1315,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1316,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1317,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1318,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1319,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1320,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1321,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1322,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1323,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1324,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1325,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1326,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1327,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1328,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1329,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1330,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1331,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1332,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1333,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1334,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1335,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1336,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1337,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1338,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1339,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1340,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1341,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1342,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1343,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1344,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1345,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1346,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1347,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1348,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1349,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1350,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1351,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1352,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1353,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1354,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1355,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1356,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1357,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1358,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1359,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1360,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1361,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1362,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1363,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1364,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1365,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1366,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1367,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1368,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1369,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1370,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1371,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1372,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1373,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1374,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1375,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1376,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1377,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1378,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1379,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1380,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1381,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1382,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1383,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1384,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1385,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1386,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1387,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1388,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1389,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1390,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1391,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1392,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1393,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1394,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1395,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1396,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1397,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1398,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1399,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1400,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1401,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1402,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1403,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1404,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1405,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1406,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1407,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1408,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1409,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1410,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1411,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1412,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1413,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1414,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1415,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1416,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1417,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1418,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1419,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1420,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1421,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1422,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1423,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1424,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1425,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1426,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1427,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1428,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1429,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1430,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1431,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1432,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1433,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1434,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1435,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1436,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1437,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1438,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1439,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1440,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1441,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1442,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1443,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1444,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1445,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1446,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1447,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1448,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1449,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1450,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1451,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1452,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1453,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1454,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1455,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1456,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1457,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1458,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1459,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1460,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1461,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1462,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1463,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1464,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1465,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1466,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1467,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1468,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1469,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1470,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1471,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1472,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1473,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1474,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1475,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1476,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1477,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1478,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1479,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1480,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1481,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1482,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1483,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1484,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1485,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1486,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1487,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1488,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1489,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1490,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1491,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1492,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1493,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1494,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1495,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1496,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1497,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1498,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1499,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1500,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1501,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1502,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1503,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1504,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1505,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1506,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1507,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1508,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1509,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1510,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1511,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1512,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1513,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1514,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1515,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1516,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1517,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1518,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1519,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1520,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1521,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1522,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1523,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1524,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1525,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1526,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1527,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1528,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1529,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1530,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1531,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1532,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1533,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1534,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1535,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1536,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1537,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1538,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1539,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1540,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1541,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1542,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1543,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1544,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1545,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1546,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1547,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1548,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1549,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1550,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1551,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1552,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1553,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1554,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1555,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1556,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1557,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1558,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1559,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1560,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1561,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1562,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1563,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1564,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1565,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1566,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1567,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1568,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1569,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1570,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1571,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1572,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1573,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1574,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1575,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1576,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1577,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1578,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1579,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1580,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1581,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1582,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1583,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1584,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1585,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1586,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1587,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1588,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1589,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1590,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1591,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1592,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1593,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1594,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1595,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1596,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1597,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1598,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1599,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1600,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1601,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1602,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1603,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1604,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1605,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1606,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1607,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1608,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1609,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1610,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1611,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1612,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1613,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1614,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1615,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1616,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1617,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1618,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1619,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1620,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1621,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1622,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1623,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1624,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1625,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1626,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1627,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1628,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1629,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1630,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1631,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1632,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1633,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1634,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1635,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1636,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1637,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1638,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1639,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1640,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1641,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1642,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1643,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1644,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1645,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1646,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1647,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1648,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1649,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1650,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1651,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1652,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1653,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1654,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1655,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1656,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1657,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1658,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1659,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1660,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1661,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1662,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1663,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1664,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1665,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1666,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1667,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1668,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1669,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319489-1-1670,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. From these, one (1) knee was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (01-Jan-2026 to 31-Mar-2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. Of these, one thousand six hundred seventy (1670) knees were later revised due to the following reasons: three hundred thirteen (313) knees due to infection, four hundred seventeen (417) knees due to loosening, one hundred eight (108) knees due to instability, one hundred forty-two (142) knees due to pain, one hundred twenty-six (126) knees due to patellofemoral pain, two hundred seventeen (217) knees due to patella erosion, fifty (50) knees due to fracture, ninety-seven (97) knees due to arthrofibrosis, eighteen (18) knees due to wear tibial insert, fifteen (15) knees due to lysis, twenty-six (26) knees due to malalignment, one (1) knee due to metal related pathology, forty-four (44) knees due to implant breakage tibial insert, fourteen (14) knees due to incorrect sizing, fourteen (14) knees due to patella maltracking, fourteen (14) knees due to bearing dislocation, eight (8) knees due to implant breakage patella, one (1) knee due to prosthesis dislocation, seven (7) knees due to synovitis, one (1) knee due to implant breakage tibial, eight (8) knees due to wear patella, one (1) knee due to implant breakage femoral, four (4) knees due to osteonecrosis, two (2) knees due to heterotopic bone, and twenty?two (22) knees due to other reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 17-Jun-2002 and 22-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II TKA System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-three thousand six hundred seven (23,607) knees underwent primary TKA between 17-Jun-2002 and 22-Dec-2025, using GENESIS II PS Non-Porous Oxinium Femoral Component with GENESIS II Tibial Component. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 1.4% (1.3%¿1.6%) vs 1.0% (1.0%¿1.0%) of the class.;- At 2nd postoperative year: 2.6% (2.4%¿2.9%) vs 1.8% (1.8%¿1.8%) of the class.;- At 3rd postoperative year: 3.5% (3.3%¿3.7%) vs 2.4% (2.4%¿2.4%) of the class.;- At 4th postoperative year: 4.2% (3.9%¿4.4%) vs 2.8% (2.8%¿2.8%) of the class.;- At 5th postoperative year: 4.7% (4.5%¿5.0%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th postoperative year: 5.2% (4.9%¿5.5%) vs 3.5% (3.4%¿3.5%) of the class.;- At 7th postoperative year: 5.6% (5.3%¿5.9%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th postoperative year: 6.0% (5.7%¿6.4%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th postoperative year: 6.4% (6.1%¿6.7%) vs 4.3% (4.3%¿4.4%) of the class.;- At 10th postoperative year: 6.8% (6.5%¿7.2%) vs 4.6% (4.6%¿4.7%) of the class.;- At 11th postoperative year: 7.3% (6.9%¿7.7%) vs 4.9% (4.9%¿5.0%) of the class.;- At 12th postoperative year: 7.8% (7.4%¿8.2%) vs 5.3% (5.2%¿5.3%) of the class.;- At 13th postoperative year: 8.2% (7.8%¿8.6%) vs 5.6% (5.5%¿5.7%) of the class.;- At 14th postoperative year: 8.5% (8.1%¿9.0%) vs 5.9% (5.9%¿6.0%) of the class.;- At 15th postoperative year: 9.0% (8.5%¿9.4%) vs 6.3% (6.2%¿6.4%) of the class.;- At 16th postoperative year: 9.5% (9.0%¿10.0%) vs 6.7% (6.6%¿6.8%) of the class.;- At 17th postoperative year: 10.3% (9.7%¿10.9%) vs 7.1% (7.0%¿7.2%) of the class.;- At 18th postoperative year: 10.7% (10.1%¿11.3%) vs 7.4% (7.3%¿7.5%) of the class.;- At 19th postoperative year: 11.0% (10.4%¿11.7%) vs 7.8% (7.7%¿7.9%) of the class.;- At 20th postoperative year: 11.4% (10.7%¿12.3%) vs 8.1% (8.0%¿8.2%) of the class.;- At 21st postoperative year: 11.8% (10.9%¿12.8%) vs 8.4% (8.3%¿8.5%) of the class.;- At 22nd postoperative year: 12.2% (11.0%¿13.4%) vs 8.7% (8.5%¿8.8%) of the class.;The confidence intervals for the yearly cumulative percent revision rates of GENESIS II PS Oxinium Femoral Component and the class do not overlap at any evaluated post-operative time point, indicating that the revision rates for GENSIS II PS Oxinium cemented are statistically significantly higher than the class throughout follow-up, based on non-overlapping 95% confidence intervals.;The percentage of patients in younger age groups (<55 and 55-64 years) was higher using GENESIS II PS Oxinium femoral components (43.5%) compared to the class (32.4%). The AOANJRR indicates that age is a major factor affecting the outcome of the primary TKA, with revision rates increasing as age at implantation decreases.;The most frequently reported reasons for revision for GENESIS II PS Oxinium Femoral Component were loosening (n= 417), patellar complications (n= 357), and infection (n= 313). Infection is recognized as a complication associated with patient and procedure related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;GENESIS II PS Oxinium knees without patellar resurfacing demonstrated a statistically significantly higher revision rate compared with knees with patellar resurfacing. Patellofemoral pain and patella erosion involve the patellar articulation and do not directly involve the GENESIS II PS Oxinium Femoral or Tibial components. The decision to resurface the patella at the time of total knee arthroplasty remains a surgeon dependent decision based on individual patient factors. It is recognized in literature that non-resurfacing of the patella may contribute to anterior knee pain, reoperation, and subsequent revisions.;Overall, the present analysis of GENESIS II PS Oxinium cemented demonstrates higher revision rates compared to the class, with patient age distribution and patella?related factors likely contributing to the observed differences. These findings are consistent with the previous clinical evaluation and do not identify new or unexpected safety concerns.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L1,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 4 LEFT,71420134,,71420134,,03596010430144,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L2,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 4 LEFT,71420134,,71420134,,03596010430144,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L3,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 4 LEFT,71420134,,71420134,,03596010430144,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L4,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 5 LEFT,71420136,,71420136,,03596010430151,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L5,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 5 LEFT,71420136,,71420136,,03596010430151,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L6,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 5 LEFT,71420136,,71420136,,03596010430151,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L7,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 6 LEFT,71420138,,71420138,,03596010430168,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L8,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 6 LEFT,71420138,,71420138,,03596010430168,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L9,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 3 RIGHT,71420148,,71420148,,03596010434678,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L10,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 3 RIGHT,71420148,,71420148,,03596010434678,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L11,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 5 RIGHT,71420152,,71420152,,03596010430182,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L12,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 5 RIGHT,71420152,,71420152,,03596010430182,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L13,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 7 RIGHT,71420156,,71420156,,03596010430816,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319490-1-L14,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II OXINIUM FEMORAL SIZE 7 RIGHT,71420156,,71420156,,03596010430816,K962557,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral component. From these, one (1) knee was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-two (32) knees underwent Revision TKA procedures between 25-Feb-2003 and 15-Dec-2009, using GENESIS II CR Oxinium femoral components. Fourteen (14) knees were later re-revised due to the following reasons: five (5) knees due to loosening, three (3) knees due to infection, one (1) knee due to pain, one (1) knee due to arthrofibrosis, one (1) knee due to malalignment, one (1) knee due to patellofemoral pain, one (1) knee due to incorrect sizing, and one (1) knee due to synovitis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 25-Feb-2003 and 15-Dec-2009 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of thirty-two (32) procedures with GENESIS II CR Oxinium femoral components have been performed in Australia between 25-Feb-2003 and 15-Dec-2009. ;;The cumulative re-revisions rates for years 1-7 are not statistically significantly different than the class, based on overlapping confidence intervals. At years 8-22, the cumulative re-revision rates are statistically significantly higher than the class based on non-overlapping confidence intervals. A higher percentage of patients aged <55 to 64 years were implanted with GENESIS II CR Oxinium femoral components in revision TKA compared to the class (53.1% versus 30.6%, respectively). For usage of Oxinium femoral components in primary THA, usage in younger patients is linked to a higher risk for revision. Three of the 14 re-revisions occurred due to infection. Complications such as infection are commonly reported after joint replacement surgery. They may occur due to the surgical environment or patients who are at high-risk. Therefore, these complications are not inherent complications of the subject device.;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 6.3% (1.6%¿22.7%) vs 4.5% (4.1%¿4.9%) of the class.;-At 2nd postoperative year: 6.3% (1.6%¿22.7%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 12.5% (4.9%¿30.0%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 21.9% (11.1%¿40.5%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 25.0% (13.4%¿43.8%) vs 14.1% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 28.1% (15.7%¿47.1%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 28.1% (15.7%¿47.1%) vs 16.1% (15.4%¿16.8%) of the class.;-At 8th postoperative year: 31.3% (18.2%¿50.3%) vs 17.1% (16.3%¿17.9%) of the class.;-At 9th postoperative year: 34.4% (20.7%¿53.4%) vs 18.1% (17.3%¿18.9%) of the class.;-At 10th postoperative year: 37.5% (23.3%¿56.5%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 37.5% (23.3%¿56.5%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 40.8% (26.1%¿59.7%) vs 20.4% (19.5%¿21.4%) of the class.;-At 13th postoperative year: 40.8% (26.1%¿59.7%) vs 21.0% (20.0%¿22.0%) of the class.;-At 14th postoperative year: 40.8% (26.1%¿59.7%) vs 21.8% (20.7%¿22.9%) of the class.;-At 15th postoperative year: 40.8% (26.1%¿59.7%) vs 22.5% (21.3%¿23.6%) of the class.;-At 16th postoperative year: 44.3% (29.0%¿63.1%) vs 22.8% (21.6%¿24.0%) of the class.;-At 17th postoperative year: 44.3% (29.0%¿63.1%) vs 23.4% (22.1%¿24.7%) of the class.;-At 18th postoperative year: 44.3% (29.0%¿63.1%) vs 23.8% (22.4%¿25.2%) of the class.;-At 19th postoperative year: 44.3% (29.0%¿63.1%) vs 24.2% (22.7%¿25.8%) of the class.;-At 20th postoperative year: 44.3% (29.0%¿63.1%) vs 25.4% (23.5%¿27.5%) of the class.;-At 21st postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;-At 22nd postoperative year: 44.3% (29.0%¿63.1%) vs 25.9% (23.8%¿28.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L1,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL SIZE 4 LEFT,71420102,,71420102,,03596010205957,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L2,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT,71420104,,71420104,,03596010205964,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L3,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT,71420104,,71420104,,03596010205964,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L4,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 6 LT,71420106,,71420106,,03596010205971,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L5,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 6 LT,71420106,,71420106,,03596010205971,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L6,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 6 LT,71420106,,71420106,,03596010205971,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L7,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 6 LT,71420106,,71420106,,03596010205971,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L8,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 3 RT,71420116,,71420116,,03596010206022,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L9,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 4 RT,71420118,,71420118,,03596010206039,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L10,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 4 RT,71420118,,71420118,,03596010206039,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L11,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 4 RT,71420118,,71420118,,03596010206039,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L12,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 5 RT,71420120,,71420120,,03596010206046,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L13,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 5 RT,71420120,,71420120,,03596010206046,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L14,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 6 RT,71420122,,71420122,,03596010206053,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L15,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GII NONPOROUS POSTERIOR STABILIZED FEMORAL SZ 7 RT,71420124,,71420124,,03596010206060,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319653-1-L16,,4/30/2026,3/16/2026,GENESIS II Total Knee System,GENESIS II POROUS POSTERIOR STABILIZED FEMORAL SIZE 4 RIGHT,71420884,,71420884,,03596010209894,K951987,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral component. From these, one (1) knee was later re revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of fifty?three (53) knees underwent Revision TKA procedures between 31-Jul-2002 and 2-Nov-2020, using GENESIS II PS CoCr femoral components. From these, sixteen (16) knees were later re-revised due to the following reasons: seven (7) knees due to loosening, three (3) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to bearing dislocation, one (1) knee due to lysis, one (1) knee due to wear ¿ patella, one (1) knee due to tumour, and one (1) knee due to other-unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 31-Jul-2002 and 2-Nov-2020 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of fifty?three (53) procedures with GENESIS II PS CoCr femoral components have been performed in Australia between 31-Jul-2002 and 2-Nov-2020. ;;The cumulative re-revisions rates for GENESIS II PS CoCr femoral components are not statistically significantly different than the class average at any time point, based on overlapping confidence intervals. Therefore, GENESIS II PS CoCr femoral components met the anticipated survivorship in the AOANJRR. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.5% (2.9%¿18.9%) vs 4.5% (4.1%¿4.8%) of the class.;-At 2nd postoperative year: 9.4% (4.0%¿21.2%) vs 7.9% (7.4%¿8.4%) of the class.;-At 3rd postoperative year: 13.2% (6.5%¿25.7%) vs 10.4% (9.9%¿11.0%) of the class.;-At 4th postoperative year: 18.9% (10.6%¿32.2%) vs 12.4% (11.8%¿13.0%) of the class.;-At 5th postoperative year: 22.6% (13.5%¿36.4%) vs 14.0% (13.4%¿14.7%) of the class.;-At 6th postoperative year: 22.6% (13.5%¿36.4%) vs 15.2% (14.5%¿15.9%) of the class.;-At 7th postoperative year: 22.6% (13.5%¿36.4%) vs 16.1% (15.4%¿16.9%) of the class.;-At 8th postoperative year: 22.6% (13.5%¿36.4%) vs 17.1% (16.4%¿17.9%) of the class.;-At 9th postoperative year: 22.6% (13.5%¿36.4%) vs 18.2% (17.4%¿19.0%) of the class.;-At 10th postoperative year: 27.6% (17.3%¿42.4%) vs 18.9% (18.1%¿19.8%) of the class.;-At 11th postoperative year: 27.6% (17.3%¿42.4%) vs 19.9% (19.0%¿20.8%) of the class.;-At 12th postoperative year: 27.6% (17.3%¿42.4%) vs 20.5% (19.6%¿21.5%) of the class.;-At 13th postoperative year: 27.6% (17.3%¿42.4%) vs 21.0% (20.1%¿22.0%) of the class.;-At 14th postoperative year: 27.6% (17.3%¿42.4%) vs 21.9% (20.8%¿23.0%) of the class.;-At 15th postoperative year: 30.9% (19.6%¿46.6%) vs 22.5% (21.4%¿23.6%) of the class.;-At 16th postoperative year: 30.9% (19.6%¿46.6%) vs 22.9% (21.7%¿24.1%) of the class.;-At 17th postoperative year: 30.9% (19.6%¿46.6%) vs 23.5% (22.2%¿24.8%) of the class.;-At 18th postoperative year: 30.9% (19.6%¿46.6%) vs 23.9% (22.5%¿25.3%) of the class.;-At 19th postoperative year: 37.8% (23.0%¿57.9%) vs 24.1% (22.7%¿25.6%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L1,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 5,71421015,,71421015,,03596010469212,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L2,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L3,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL LEFT SIZE 7,71421017,,71421017,,03596010469236,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L4,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM P/S FEMORAL LT SZ 8,71421018,,71421018,,03596010469243,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L5,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 3,71421113,,71421113,,03596010469274,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L6,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 4,71421114,,71421114,,03596010469281,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L7,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L8,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 5,71421115,,71421115,,03596010469298,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L9,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM POSTERIOR STABILIZED FEMORAL RIGHT SIZE 6,71421116,,71421116,,03596010469304,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00319700-1-L10,,4/30/2026,3/16/2026,GENESIS II PS Oxinium Femoral Component ,GENESIS II OXINIUM P/S FEMORAL RT SZ 7,71421117,,71421117,,03596010469311,K962557,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component implanted. Of these, one (1) knee required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of forty-five (45) knees underwent revision TKA between 08-Oct-2004 and 08-Apr-2025 in which a GENESIS II PS Oxinium Femoral Component was implanted. Of these, ten (10) knees required re-revision due to the following reasons: two (2) knees due to loosening, five (5) knees due to infection, one (1) knee due to arthrofibrosis, one (1) knee due to patella erosion, one (1) knee due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 08-Oct-2004 and 08-Apr-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the GENESIS II Total Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-five (45) knees underwent revision TKA in which a GENESIS II PS Oxinium Femoral Component was implanted in Australia between 08-Oct-2004 and 08-Apr-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st postoperative year: 6.7% (2.2%¿19.4%) vs 4.5% (4.1%¿4.9%) of the class;- At 2nd postoperative year: 9.0% (3.5%¿22.2%) vs 7.9% (7.4%¿8.4%) of the class;- At 3rd postoperative year: 13.7% (6.4%¿28.1%) vs 10.4% (9.9%¿11.0%) of the class;- At 4th postoperative year: 18.7% (9.8%¿33.9%) vs 12.4% (11.8%¿13.0%) of the class;- At 5th postoperative year: 18.7% (9.8%¿33.9%) vs 14.1% (13.4%¿14.8%) of the class;- At 6th postoperative year: 18.7% (9.8%¿33.9%) vs 15.2% (14.5%¿15.9%) of the class;- At 7th postoperative year: 18.7% (9.8%¿33.9%) vs 16.1% (15.4%¿16.9%) of the class;- At 8th postoperative year: 21.4% (11.7%¿37.2%) vs 17.1% (16.4%¿17.9%) of the class;- At 9th postoperative year: 21.4% (11.7%¿37.2%) vs 18.2% (17.4%¿19.0%) of the class;- At 10th postoperative year: 24.6% (14.0%¿41.3%) vs 19.0% (18.1%¿19.8%) of the class;- At 11th postoperative year: 24.6% (14.0%¿41.3%) vs 19.9% (19.1%¿20.9%) of the class;- At 12th postoperative year: 24.6% (14.0%¿41.3%) vs 20.5% (19.6%¿21.5%) of the class;- At 13th postoperative year: 24.6% (14.0%¿41.3%) vs 21.1% (20.1%¿22.1%) of the class;- At 14th postoperative year: 24.6% (14.0%¿41.3%) vs 21.9% (20.8%¿23.0%) of the class;- At 15th postoperative year: 24.6% (14.0%¿41.3%) vs 22.5% (21.4%¿23.7%) of the class;- At 16th postoperative year: 24.6% (14.0%¿41.3%) vs 23.0% (21.8%¿24.2%) of the class;- At 17th postoperative year: 24.6% (14.0%¿41.3%) vs 23.6% (22.3%¿24.9%) of the class;- At 18th postoperative year: 24.6% (14.0%¿41.3%) vs 23.9% (22.6%¿25.4%) of the class;By observing the cumulative re?revision rates above, it can be determined that there is no statistically significant difference between the re?revision rates of the GENESIS?II?PS?Oxinium Femoral Component and the revision TKA class, as determined by overlapping 95% confidence intervals at all postoperative time points from Year?1 through Year?18.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION KNEE REPLACEMENT PROCEDURES: 1. PRIMARY UKA PROCEDURES: - GENESIS UNI FEMORAL COMPONENTS: IMPLANTED IN TWO THOUSAND ONE HUNDRED AND NINETY-EIGHT (2,198) KNEES BETWEEN (B)(6) 1999 AND (B)(6) 2014. THESE INCLUDE SIZE VARIANTS CERTIFIED FOR USE IN THE UNITED STATES UNDER PRO CODES HSX, JWH AND JDI. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FIVE HUNDRED SIX (506) CASES DUE TO THE FOLLOWING COMPLICATIONS: ONE HUNDRED AND EIGHTY-SEVEN (187) KNEES DUE TO PROGRESSION OF DISEASE, TWO HUNDRED AND EIGHTEEN (218) KNEES DUE TO LOOSENING, THIRTY (30) KNEES DUE TO PAIN, TWELVE (12) KNEES DUE TO INFECTION, FOURTEEN (14) KNEES DUE TO LYSIS, THREE (3) KNEES DUE TO FRACTURE, NINE (9) KNEES DUE TO WEAR OF TIBIAL INSERT, FIVE (5) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO MALALIGNMENT, FIVE (5) KNEES DUE TO IMPLANT BREAKAGE ASSOCIATED WITH THE TIBIAL COMPONENT, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, FOUR (4) KNEES DUE TO TIBIAL WEAR, TWO (2) KNEES DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO INCORRECT SIZING, FIVE (5) KNEES DUE TO OSTEONECROSIS, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO PATELLA EROSION AND TWO (2) KNEES DUE TO OTHER-UNSPECIFIED REASONS. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 506 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE JWH. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 506 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF (B)(4) INCLUDES ONLY 376 REVISIONS ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS UNI FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE JWH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 376 CASES. 2. PRIMARY TKA PROCEDURES: JOURNEY II BCS OXINIUM FEMORAL COMPONENTS: IMPLANTED IN FOUR THOUSAND FIVE HUNDRED AND TWENTY-FIVE (4,525) KNEES BETWEEN (B)(6) 2013 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FORTY-FOUR (44) CASES DUE TO THE FOLLOWING COMPLICATIONS: NINETEEN (19) KNEES DUE TO INFECTION, SIX (6) KNEES DUE TO INSTABILITY, FOUR (4) KNEES DUE TO LOOSENING, FOUR (4) KNEES DUE TO PAIN, FOUR (4) KNEES DUE TO FRACTURE, TWO (2) KNEES DUE TO PATELLA EROSION, ONE (1) KNEE DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO WEAR OF THE TIBIAL INSERT, AND ONE (1) KNEE DUE TO SYNOVITIS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. LEGION TOTAL KNEE SYSTEM POROUS TIBIAL BASEPLATES WITHOUT HOLES: IMPLANTED IN FOUR HUNDRED AND SIXTY-EIGHT (468) KNEES BETWEEN (B)(6) 2018 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SIX (6) CASES DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) DUE TO INFECTION, THREE (3) DUE TO LOOSENING, ONE (1) DUE TO PAIN, AND ONE (1) DUE TO PATELLA MALTRACKING. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. LEGION CRUCIATE RETAINING (CR) COBALT-CHROMIUM (COCR) NON-POROUS FEMORAL COMPONENTS: IMPLANTED IN FIVE THOUSAND THREE-HUNDRED AND FIFTEEN (5,315) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN ONE HUNDRED AND FIFTY (150) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTY-SEVEN (57) HIPS DUE TO INFECTION, TWENTY-ONE (21) DUE TO LOOSENING, THIRTEEN (13) DUE TO INSTABILITY, TWELVE (12) DUE TO PAIN, SEVEN (7) DUE TO PATELLOFEMORAL PAIN, SIXTEEN (16) DUE TO PATELLA EROSION, ONE (1) DUE TO FRACTURE, SIX (6) DUE TO ARTHROFIBROSIS, THREE (3) DUE TO LYSIS, FOUR (4) DUE TO MALALIGNMENT, ONE (1) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO PROSTHESIS DISLOCATION, FIVE (5) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) COBALT-CHROMIUM (COCR) NON-POROUS FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN SIX THOUSAND SIX-HUNDRED AND EIGHTY-EIGHT (6,688) KNEES BETWEEN (B)(6) 2008 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWO-HUNDRED AND FORTY-THREE (243) CASES DUE TO THE FOLLOWING COMPLICATIONS: A HUNDRED AND SEVEN (107) KNEES DUE TO INFECTION, FIFTY-ONE (51) DUE TO LOOSENING, SEVENTEEN (17) DUE TO INSTABILITY, EIGHT (8) DUE TO PAIN, FOUR (4) DUE TO PATELLOFEMORAL PAIN, SIX (6) DUE TO PATELLA EROSION, FIFTEEN (15) DUE TO FRACTURE, ELEVEN (11) DUE TO ARTHROFIBROSIS, EIGHT (8) DUE TO MALALIGNMENT, ONE (1) DUE TO METAL RELATED PATHOLOGY, THREE (3) DUE TO INCORRECT SIZING, TWO (2) DUE TO PATELLA MALTRACKING, THREE (3) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO WEAR PATELLA, FIVE (5) DUE TO OTHER CAUSES. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION CRUCIATE RETAINING (CR) OXINIUM FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN THIRTEEN THOUSAND AND NINETY-ONE (13,091) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN THREE HUNDRED AND EIGHTY-ONE (381) CASES DUE TO THE FOLLOWING COMPLICATIONS: EIGHTY-SEVEN (87) KNEES DUE TO INFECTION, SEVENTY-TWO (72) DUE TO LOOSENING, FIFTY-EIGHT (58) DUE TO INSTABILITY, THIRTY-SIX (36) DUE TO PAIN, FOURTEEN (14) DUE TO PATELLOFEMORAL PAIN, FORTY-EIGHT (48) DUE TO PATELLA EROSION, TWELVE (12) DUE TO FRACTURE, TWENTY-FIVE (25) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO WEAR TIBIAL INSERT, TEN (10) DUE TO MALALIGNMENT, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, FIVE (5) DUE TO INCORRECT SIZING, FOUR (4) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL, ONE (1) DUE TO WEAR PATELLA, TWO (2) DUE TO OSTEONECROSIS, TWO (2) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) OXINIUM FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN TWENTY THOUSAND AND FIFTY-FOUR (20,054) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN EIGHT HUNDRED AND FIFTY (850) CASES DUE TO THE FOLLOWING COMPLICATIONS: TWO HUNDRED THREE (203) KNEES DUE TO INFECTION, ONE HUNDRED SEVENTY-FIVE (175) DUE TO LOOSENING, ONE HUNDRED ONE (101) DUE TO INSTABILITY, SIXTY-ONE (61) DUE TO PAIN, FIFTY-FOUR (54) DUE TO PATELLOFEMORAL PAIN, FORTY-SEVEN (47) DUE TO PATELLA EROSION, THIRTY-SEVEN (37) DUE TO FRACTURE, FORTY-EIGHT (48) DUE TO ARTHROFIBROSIS, TEN (10) DUE TO WEAR TIBIAL INSERT, SEVEN (7) DUE TO LYSIS, NINETEEN (19) DUE TO MALALIGNMENT, FORTY-ONE (41) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, SIX (6) DUE TO INCORRECT SIZING, SIX (6) DUE TO PATELLA MALTRACKING, TEN (10) DUE TO BEARING DISLOCATION, SIX (6) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO SYNOVITIS, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL, ONE (1) DUE TO WEAR PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE FEMORAL, FIVE (5) DUE TO OSTEONECROSIS, ONE (1) DUE TO HETEROTOPIC BONE, NINE (9) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION REVISION TIBIAL BASEPLATE: IMPLANTED IN NINE HUNDRED SEVENTY-EIGHT (978) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SEVENTY-EIGHT (78) CASES DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-FOUR (34) KNEES DUE TO INFECTION, TEN (10) DUE TO LOOSENING, EIGHT (8) DUE TO INSTABILITY, FIVE (5) DUE TO PAIN, TWO (2) DUE TO PATELLOFEMORAL PAIN, TWO (2) DUE TO PATELLA EROSION, FIVE (5) DUE TO FRACTURE, TWO (2) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO PATELLA MALTRACKING, SEVEN (7) DUE TO BEARING DISLOCATION, ONE (1) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL TIBIAL BASEPLATES PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) OR CRUCIATE RETAINING (CR) HIGH FLEX INSERTS: IMPLANTED IN SIXTY-TWO THOUSAND FOUR HUNDRED AND THIRTY-ONE (62,431) KNEES BETWEEN (B)(6) 2010 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWO THOUSAND AND SEVENTY-SIX (2,176) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIX HUNDRED NINETEEN (619) KNEES DUE TO INFECTION, FOUR HUNDRED TWENTY-ONE (421) DUE TO LOOSENING, ONE HUNDRED EIGHTY (180) DUE TO INSTABILITY, ONE HUNDRED SEVENTY-THREE (173) DUE TO PAIN, NINETY-SEVEN (97) DUE TO PATELLOFEMORAL PAIN, ONE HUNDRED SIXTY-NINE (169) DUE TO PATELLA EROSION, SEVENTY-NINE (79) DUE TO FRACTURE, ONE HUNDRED FORTY-SEVEN (147) DUE TO ARTHROFIBROSIS, FIFTY-THREE (53) DUE TO MALALIGNMENT, FOURTEEN (14) DUE TO LYSIS, FOURTEEN (14) DUE TO WEAR TIBIAL INSERT, FOUR (4) DUE TO METAL RELATED PATHOLOGY, TWENTY-SEVEN (27) DUE TO INCORRECT SIZING, FIFTY-FOUR (54) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, TWENTY-TWO (22) DUE TO PATELLA MALTRACKING, EIGHTEEN (18) DUE TO BEARING DISLOCATION, TWELVE (12) DUE TO IMPLANT BREAKAGE PATELLA, FOUR (4) DUE TO PROSTHESIS DISLOCATION, SEVEN (7) DUE TO SYNOVITIS, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL, NINE (9) DUE TO WEAR PATELLA, NINE (9) DUE TO OSTEONECROSIS, FOUR (4) DUE TO IMPLANT BREAKAGE FEMORAL, FOUR (4) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO PROGRESSION OF DISEASE, THIRTY-THREE (33) DUE TO OTHER-UNSPECIFIED REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION CONSTRAINED ARTICULAR INSERT: IMPLANTED IN FOUR HUNDRED AND FIFTY (450) KNEES BETWEEN (B)(6) 2007 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN THIRTY-SEVEN (37) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTEEN (15) KNEES DUE TO INFECTION, FIVE (5) DUE TO LOOSENING, FIVE (5) DUE TO INSTABILITY, FOUR (4) DUE TO PAIN, ONE (1) DUE TO PATELLOFEMORAL PAIN, ONE (1) DUE TO PATELLA EROSION, ONE (1) DUE TO FRACTURE, ONE (1) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO PATELLA MALTRACKING, THREE (3) DUE TO BEARING DISLOCATION. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION CRUCIATE RETAINING (CR) DEEP-DISH XLPE INSERT: IMPLANTED IN THREE THOUSAND EIGHT-HUNDRED AND SIX (3,806) KNEES BETWEEN (B)(6) 2018 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SEVENTY-EIGHT (78) CASES DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-ONE (31) KNEES DUE TO INFECTION, TWELVE (12) DUE TO LOOSENING, SIX (6) DUE TO INSTABILITY, FIVE (5) DUE TO PAIN, SEVEN (7) DUE TO PATELLA EROSION, SEVEN (7) DUE TO ARTHROFIBROSIS, TWO (2) DUE TO FRACTURE, TWO (2) DUE TO MALALIGNMENT, TWO (2) DUE TO INCORRECT SIZING, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, TWO (2) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO WEAR PATELLA. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT: IMPLANTED IN FIVE HUNDRED FORTY-SIX (546) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FORTY-EIGHT (48) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIXTEEN (16) KNEES DUE TO INFECTION, EIGHT (8) KNEES DUE TO LOOSENING, FOUR (4) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO PAIN, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO PATELLA EROSION, THREE (3) KNEES DUE TO PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO PATELLA MALTRACKING, AND FIVE (5) KNEES DUE TO BEARING DISLOCATION. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. GENESIS II NON-POROUS CR COCR FEMORAL COMPONENT: IMPLANTED IN EIGHTEEN THOUSAND TWO HUNDRED AND SEVENTY-THREE (18,273) KNEES BETWEEN (B)(6) 1999 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN EIGHT HUNDRED AND EIGHTEEN (818) KNEES DUE TO THE FOLLOWING REASONS: TWO HUNDRED TWENTY-EIGHT (228) KNEES DUE TO INFECTION, ONE HUNDRED FORTY-EIGHT (148) DUE TO LOOSENING, SEVENTY-TWO (72) DUE TO INSTABILITY, EIGHTY-NINE (89) DUE TO PAIN, SIXTY-TWO (62) DUE TO PATELLOFEMORAL PAIN, SEVENTY-SEVEN (77) DUE TO PATELLA EROSION, THIRTY-SEVEN (37) DUE TO FRACTURE, THIRTY-TWO (32) DUE TO ARTHROFIBROSIS, SEVEN (7) DUE TO WEAR TIBIAL INSERT, NINE (9) DUE TO LYSIS, SEVENTEEN (17) DUE TO MALALIGNMENT, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, THREE (3) DUE TO METAL RELATED PATHOLOGY, SEVEN (7) DUE TO INCORRECT SIZING, TEN (10) DUE TO PATELLA MALTRACKING, NINE (9) DUE TO BEARING DISLOCATION, ONE (1) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO WEAR PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE FEMORAL, TWO (2) DUE TO OSTEONECROSIS, AND FIVE (5) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. GENESIS II NON-POROUS PS COCR FEMORAL COMPONENT: IMPLANTED IN TWENTY THOUSAND SIX HUNDRED AND ONE (20,601) KNEES BETWEEN (B)(6) 1999 AND (B)(6) 2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN NINE HUNDRED AND FORTY-FIVE (945) KNEES DUE TO THE FOLLOWING REASONS: THREE HUNDRED TWO (302) KNEES DUE TO INFECTION, ONE HUNDRED EIGHTY-FOUR (184) DUE TO LOOSENING, SIXTY-FOUR (64) DUE TO INSTABILITY, ONE HUNDRED (100) DUE TO PAIN, SEVENTY-EIGHT (78) DUE TO PATELLOFEMORAL PAIN, FORTY-SIX (46) DUE TO PATELLA EROSION, FORTY-THREE (43) DUE TO FRACTURE, TWENTY-NINE (29) DUE TO ARTHROFIBROSIS, TEN (10) DUE TO WEAR TIBIAL INSERT, EIGHT (8) DUE TO LYSIS, NINETEEN (19) DUE TO MALALIGNMENT, THIRTEEN (13) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, FIVE (5) DUE TO METAL RELATED PATHOLOGY, SEVEN (7) DUE TO INCORRECT SIZING, SEVEN (7) DUE TO PATELLA MALTRACKING, ELEVEN (11) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, TWO (2) DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO SYNOVITIS, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL, THREE (3) DUE TO WEAR PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE FEMORAL, ONE (1) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO WEAR TIBIAL, SIX (6) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. 3. REVISION TKA PROCEDURES: LEGION REVISION TIBIAL BASEPLATE: IMPLANTED IN ONE THOUSAND FIVE-HUNDRED AND FOURTEEN (1514) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN TWO HUNDRED AND FOUR (204) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIXTY-THREE (63) KNEES DUE TO LOOSENING, FIFTY-NINE (59) DUE TO INFECTION, TWENTY (20) DUE TO INSTABILITY, EIGHTEEN (18) DUE TO PAIN, NINE (9) DUE TO ARTHROFIBROSIS, FOUR (4) DUE TO MALALIGNMENT, FOUR (4) DUE TO PATELLOFEMORAL PAIN, THREE (3) DUE TO PATELLA EROSION, ONE (1) DUE TO LYSIS, FOUR (4) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO METAL RELATED PATHOLOGY, ONE (1) DUE TO WEAR TIBIAL INSERT, ONE (1) DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, TWO (2) DUE TO WEAR PATELLA, FOUR (4) DUE TO OTHER REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH RE-REVISION CASE. LEGION POSTERIOR STABILIZED (PS) OXINIUM FEMORAL COMPONENT: IMPLANTED IN FIFTY-SIX (56) KNEES BETWEEN (B)(6) 2010 AND (B)(6) 2024. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN SIXTEEN (16) CASES DUE TO THE FOLLOWING COMPLICATIONS: THREE (3) KNEES DUE TO ARTHROFIBROSIS, THREE (3) DUE TO INSTABILITY, SEVEN (7) DUE TO LOOSENING, ONE (1) DUE TO PAIN, TWO (2) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR RE-REVISION. LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT: IMPLANTED IN ONE THOUSAND THREE HUNDRED FIFTY-EIGHT (1358) KNEES BETWEEN (B)(6) 2006 AND (B)(6) 2025. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN ONE HUNDRED AND EIGHTY-EIGHT (188) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTY-EIGHT (58) KNEES DUE TO LOOSENING, FIFTY (50) KNEES DUE TO INFECTION, TWENTY-TWO (22) KNEES DUE TO INSTABILITY, SEVENTEEN (17) KNEES DUE TO PAIN, EIGHT (8) KNEES DUE TO ARTHROFIBROSIS, FOUR (4) KNEES DUE TO MALALIGNMENT, FOUR (4) KNEES DUE TO PATELLOFEMORAL PAIN, TWO (2) KNEES DUE TO PATELLA EROSION, ONE (1) KNEE DUE TO PERIPROSTHETIC FRACTURE, ONE (1) KNEE DUE TO METAL RELATED PATHOLOGY, TWO (2) KNEES DUE TO PATELLA MALTRACKING, NINE (9) KNEES DUE TO BEARING DISLOCATION, ONE (1) KNEE DUE TO WEAR TIBIAL INSERT, ONE (1) KNEE DUE TO IMPLANT BREAKAGE TIBIAL INSERT, ONE (1) KNEE DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) KNEE DUE TO PROSTHESIS DISLOCATION, ONE (1) KNEE DUE TO SYNOVITIS, AND FIVE (5) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH RE-REVISION CASE. ALTOGETHER, A TOTAL QUANTITY OF THREE HUNDRED AND SEVENTY-SIX (376) UKA REVISIONS, FIVE THOUSAND EIGHT HUNDRED AND FIFTY-FOUR (5854) TKA REVISIONS AND FOUR HUNDRED AND EIGHT (408) RE-REVISION TKA SURGERIES, (6638 EVENTS IN TOTAL), HAVE BEEN REPORTED IN THE AOANJRR FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY UKA PROCEDURES: GENESIS UNI FEMORAL COMPONENTS: IMPLANTED IN TWO THOUSAND ONE HUNDRED AND NINETY-EIGHT (2,198) KNEES BETWEEN 15-NOV-1999 AND 03-FEB-2014. THESE INCLUDE SIZE VARIANTS CERTIFIED FOR USE IN THE UNITED STATES UNDER PRO CODES HSX, JWH AND JDI. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FIVE HUNDRED SIX (506) CASES DUE TO THE FOLLOWING COMPLICATIONS: ONE HUNDRED AND EIGHTY-SEVEN (187) KNEES DUE TO PROGRESSION OF DISEASE, TWO HUNDRED AND EIGHTEEN (218) KNEES DUE TO LOOSENING, THIRTY (30) KNEES DUE TO PAIN, TWELVE (12) KNEES DUE TO INFECTION, FOURTEEN (14) KNEES DUE TO LYSIS, THREE (3) KNEES DUE TO FRACTURE, NINE (9) KNEES DUE TO WEAR OF TIBIAL INSERT, FIVE (5) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO MALALIGNMENT, FIVE (5) KNEES DUE TO IMPLANT BREAKAGE ASSOCIATED WITH THE TIBIAL COMPONENT, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, FOUR (4) KNEES DUE TO TIBIAL WEAR, TWO (2) KNEES DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO INCORRECT SIZING, FIVE (5) KNEES DUE TO OSTEONECROSIS, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO PATELLA EROSION AND TWO (2) KNEES DUE TO OTHER-UNSPECIFIED REASONS. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 506 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE JWH. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 506 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 376 REVISIONS ASSOCIATED WITH KNEES THAT HAD PREVIOUSLY RECEIVED A GENESIS UNI FEMORAL COMPONENT APPROVED UNDER FDA PRODUCT CODE JWH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 376 CASES. 2. PRIMARY TKA PROCEDURES: JOURNEY II BCS OXINIUM FEMORAL COMPONENTS: IMPLANTED IN FOUR THOUSAND FIVE HUNDRED AND TWENTY-FIVE (4,525) KNEES BETWEEN 26-AUG-13 AND 30-APR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FORTY-FOUR (44) CASES DUE TO THE FOLLOWING COMPLICATIONS: NINETEEN (19) KNEES DUE TO INFECTION, SIX (6) KNEES DUE TO INSTABILITY, FOUR (4) KNEES DUE TO LOOSENING, FOUR (4) KNEES DUE TO PAIN, FOUR (4) KNEES DUE TO FRACTURE, TWO (2) KNEES DUE TO PATELLA EROSION, ONE (1) KNEE DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO WEAR OF THE TIBIAL INSERT, AND ONE (1) KNEE DUE TO SYNOVITIS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. LEGION TOTAL KNEE SYSTEM POROUS TIBIAL BASEPLATES WITHOUT HOLES: IMPLANTED IN FOUR HUNDRED AND SIXTY-EIGHT (468) KNEES BETWEEN 16-AUG-2018 AND 27-FEB-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SIX (6) CASES DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) DUE TO INFECTION, THREE (3) DUE TO LOOSENING, ONE (1) DUE TO PAIN, AND ONE (1) DUE TO PATELLA MALTRACKING. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. LEGION CRUCIATE RETAINING (CR) COBALT-CHROMIUM (COCR) NON-POROUS FEMORAL COMPONENTS: IMPLANTED IN FIVE THOUSAND THREE-HUNDRED AND FIFTEEN (5,315) KNEES BETWEEN 19-MAY-2006 AND 07-MAR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN ONE HUNDRED AND FIFTY (150) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTY-SEVEN (57) HIPS DUE TO INFECTION, TWENTY-ONE (21) DUE TO LOOSENING, THIRTEEN (13) DUE TO INSTABILITY, TWELVE (12) DUE TO PAIN, SEVEN (7) DUE TO PATELLOFEMORAL PAIN, SIXTEEN (16) DUE TO PATELLA EROSION, ONE (1) DUE TO FRACTURE, SIX (6) DUE TO ARTHROFIBROSIS, THREE (3) DUE TO LYSIS, FOUR (4) DUE TO MALALIGNMENT, ONE (1) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO PROSTHESIS DISLOCATION, FIVE (5) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) COBALT-CHROMIUM (COCR) NON-POROUS FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN SIX THOUSAND SIX-HUNDRED AND EIGHTY-EIGHT (6,688) KNEES BETWEEN 14-MAY-2008 AND 27-FEB-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWO-HUNDRED AND FORTY-THREE (243) CASES DUE TO THE FOLLOWING COMPLICATIONS: A HUNDRED AND SEVEN (107) KNEES DUE TO INFECTION, FIFTY-ONE (51) DUE TO LOOSENING, SEVENTEEN (17) DUE TO INSTABILITY, EIGHT (8) DUE TO PAIN, FOUR (4) DUE TO PATELLOFEMORAL PAIN, SIX (6) DUE TO PATELLA EROSION, FIFTEEN (15) DUE TO FRACTURE, ELEVEN (11) DUE TO ARTHROFIBROSIS, EIGHT (8) DUE TO MALALIGNMENT, ONE (1) DUE TO METAL RELATED PATHOLOGY, THREE (3) DUE TO INCORRECT SIZING, TWO (2) DUE TO PATELLA MALTRACKING, THREE (3) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO WEAR PATELLA, FIVE (5) DUE TO OTHER CAUSES. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION CRUCIATE RETAINING (CR) OXINIUM FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN THIRTEEN THOUSAND AND NINETY-ONE (13,091) KNEES BETWEEN 13-SEP-2006 AND 07-MAR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN THREE HUNDRED AND EIGHTY-ONE (381) CASES DUE TO THE FOLLOWING COMPLICATIONS: EIGHTY-SEVEN (87) KNEES DUE TO INFECTION, SEVENTY-TWO (72) DUE TO LOOSENING, FIFTY-EIGHT (58) DUE TO INSTABILITY, THIRTY-SIX (36) DUE TO PAIN, FOURTEEN (14) DUE TO PATELLOFEMORAL PAIN, FORTY-EIGHT (48) DUE TO PATELLA EROSION, TWELVE (12) DUE TO FRACTURE, TWENTY-FIVE (25) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO WEAR TIBIAL INSERT, TEN (10) DUE TO MALALIGNMENT, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, FIVE (5) DUE TO INCORRECT SIZING, FOUR (4) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO BEARING DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL, ONE (1) DUE TO WEAR PATELLA, TWO (2) DUE TO OSTEONECROSIS, TWO (2) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) OXINIUM FEMORAL COMPONENT (STANDARD OR NARROW): IMPLANTED IN TWENTY THOUSAND AND FIFTY-FOUR (20,054) KNEES BETWEEN 01-JUN-2006 AND 10-MAR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN EIGHT HUNDRED AND FIFTY (850) CASES DUE TO THE FOLLOWING COMPLICATIONS: TWO HUNDRED THREE (203) KNEES DUE TO INFECTION, ONE HUNDRED SEVENTY-FIVE (175) DUE TO LOOSENING, ONE HUNDRED ONE (101) DUE TO INSTABILITY, SIXTY-ONE (61) DUE TO PAIN, FIFTY-FOUR (54) DUE TO PATELLOFEMORAL PAIN, FORTY-SEVEN (47) DUE TO PATELLA EROSION, THIRTY-SEVEN (37) DUE TO FRACTURE, FORTY-EIGHT (48) DUE TO ARTHROFIBROSIS, TEN (10) DUE TO WEAR TIBIAL INSERT, SEVEN (7) DUE TO LYSIS, NINETEEN (19) DUE TO MALALIGNMENT, FORTY-ONE (41) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, SIX (6) DUE TO INCORRECT SIZING, SIX (6) DUE TO PATELLA MALTRACKING, TEN (10) DUE TO BEARING DISLOCATION, SIX (6) DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) DUE TO SYNOVITIS, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL, ONE (1) DUE TO WEAR PATELLA, ONE (1) DUE TO IMPLANT BREAKAGE FEMORAL, FIVE (5) DUE TO OSTEONECROSIS, ONE (1) DUE TO HETEROTOPIC BONE, NINE (9) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL FEMORAL COMPONENT PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION REVISION TIBIAL BASEPLATE: IMPLANTED IN NINE HUNDRED SEVENTY-EIGHT (978) KNEES BETWEEN 16-MAY-2006 AND 28-JAN-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SEVENTY-EIGHT (78) CASES DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-FOUR (34) KNEES DUE TO INFECTION, TEN (10) DUE TO LOOSENING, EIGHT (8) DUE TO INSTABILITY, FIVE (5) DUE TO PAIN, TWO (2) DUE TO PATELLOFEMORAL PAIN, TWO (2) DUE TO PATELLA EROSION, FIVE (5) DUE TO FRACTURE, TWO (2) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO PATELLA MALTRACKING, SEVEN (7) DUE TO BEARING DISLOCATION, ONE (1) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO IMPLANT BREAKAGE TIBIAL. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL TIBIAL BASEPLATES PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION POSTERIOR STABILIZED (PS) OR CRUCIATE RETAINING (CR) HIGH FLEX INSERTS: IMPLANTED IN SIXTY-TWO THOUSAND FOUR HUNDRED AND THIRTY-ONE (62,431) KNEES BETWEEN 08-APR-2010 AND 04-APR-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN TWO THOUSAND AND SEVENTY-SIX (2,176) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIX HUNDRED NINETEEN (619) KNEES DUE TO INFECTION, FOUR HUNDRED TWENTY-ONE (421) DUE TO LOOSENING, ONE HUNDRED EIGHTY (180) DUE TO INSTABILITY, ONE HUNDRED SEVENTY-THREE (173) DUE TO PAIN, NINETY-SEVEN (97) DUE TO PATELLOFEMORAL PAIN, ONE HUNDRED SIXTY-NINE (169) DUE TO PATELLA EROSION, SEVENTY-NINE (79) DUE TO FRACTURE, ONE HUNDRED FORTY-SEVEN (147) DUE TO ARTHROFIBROSIS, FIFTY-THREE (53) DUE TO MALALIGNMENT, FOURTEEN (14) DUE TO LYSIS, FOURTEEN (14) DUE TO WEAR TIBIAL INSERT, FOUR (4) DUE TO METAL RELATED PATHOLOGY, TWENTY-SEVEN (27) DUE TO INCORRECT SIZING, FIFTY-FOUR (54) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, TWENTY-TWO (22) DUE TO PATELLA MALTRACKING, EIGHTEEN (18) DUE TO BEARING DISLOCATION, TWELVE (12) DUE TO IMPLANT BREAKAGE PATELLA, FOUR (4) DUE TO PROSTHESIS DISLOCATION, SEVEN (7) DUE TO SYNOVITIS, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL, NINE (9) DUE TO WEAR PATELLA, NINE (9) DUE TO OSTEONECROSIS, FOUR (4) DUE TO IMPLANT BREAKAGE FEMORAL, FOUR (4) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO PROGRESSION OF DISEASE, THIRTY-THREE (33) DUE TO OTHER-UNSPECIFIED REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. LEGION CONSTRAINED ARTICULAR INSERT: IMPLANTED IN FOUR HUNDRED AND FIFTY (450) KNEES BETWEEN 12-JAN-2007 AND 28-JAN-25. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN THIRTY-SEVEN (37) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTEEN (15) KNEES DUE TO INFECTION, FIVE (5) DUE TO LOOSENING, FIVE (5) DUE TO INSTABILITY, FOUR (4) DUE TO PAIN, ONE (1) DUE TO PATELLOFEMORAL PAIN, ONE (1) DUE TO PATELLA EROSION, ONE (1) DUE TO FRACTURE, ONE (1) DUE TO ARTHROFIBROSIS, ONE (1) DUE TO PATELLA MALTRACKING, THREE (3) DUE TO BEARING DISLOCATION. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION CRUCIATE RETAINING (CR) DEEP-DISH XLPE INSERT: IMPLANTED IN THREE THOUSAND EIGHT-HUNDRED AND SIX (3,806) KNEES BETWEEN 24-JUL-2018 AND 27-FEB-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN SEVENTY-EIGHT (78) CASES DUE TO THE FOLLOWING COMPLICATIONS: THIRTY-ONE (31) KNEES DUE TO INFECTION, TWELVE (12) DUE TO LOOSENING, SIX (6) DUE TO INSTABILITY, FIVE (5) DUE TO PAIN, SEVEN (7) DUE TO PATELLA EROSION, SEVEN (7) DUE TO ARTHROFIBROSIS, TWO (2) DUE TO FRACTURE, TWO (2) DUE TO MALALIGNMENT, TWO (2) DUE TO INCORRECT SIZING, ONE (1) DUE TO IMPLANT BREAKAGE PATELLA, TWO (2) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO WEAR PATELLA. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. - LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT: IMPLANTED IN FIVE HUNDRED FORTY-SIX (546) KNEES BETWEEN 25-MAY-2006 AND 28-JAN-2025. SUBSEQUENT REVISION SURGERIES WERE REPORTED IN FORTY-EIGHT (48) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIXTEEN (16) KNEES DUE TO INFECTION, EIGHT (8) KNEES DUE TO LOOSENING, FOUR (4) KNEES DUE TO INSTABILITY, FIVE (5) KNEES DUE TO PAIN, TWO (2) KNEES DUE TO PATELLOFEMORAL PAIN, ONE (1) KNEE DUE TO PATELLA EROSION, THREE (3) KNEES DUE TO PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO ARTHROFIBROSIS, ONE (1) KNEE DUE TO METAL RELATED PATHOLOGY, ONE (1) KNEE DUE TO PATELLA MALTRACKING, AND FIVE (5) KNEES DUE TO BEARING DISLOCATION. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. 3. REVISION TKA PROCEDURES: - LEGION REVISION TIBIAL BASEPLATE: IMPLANTED IN ONE THOUSAND FIVE-HUNDRED AND FOURTEEN (1514) KNEES BETWEEN 23-MAY-2006 AND 11-FEB-2025. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN TWO HUNDRED AND FOUR (204) CASES DUE TO THE FOLLOWING COMPLICATIONS: SIXTY-THREE (63) KNEES DUE TO LOOSENING, FIFTY-NINE (59) DUE TO INFECTION, TWENTY (20) DUE TO INSTABILITY, EIGHTEEN (18) DUE TO PAIN, NINE (9) DUE TO ARTHROFIBROSIS, FOUR (4) DUE TO MALALIGNMENT, FOUR (4) DUE TO PATELLOFEMORAL PAIN, THREE (3) DUE TO PATELLA EROSION, ONE (1) DUE TO LYSIS, FOUR (4) DUE TO PATELLA MALTRACKING, ONE (1) DUE TO METAL RELATED PATHOLOGY, ONE (1) DUE TO WEAR TIBIAL INSERT, ONE (1) DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE TIBIAL INSERT, TWO (2) DUE TO WEAR PATELLA, FOUR (4) DUE TO OTHER REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE AOANJRR JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH RE-REVISION CASE. - LEGION POSTERIOR STABILIZED (PS) OXINIUM FEMORAL COMPONENT: IMPLANTED IN FIFTY-SIX (56) KNEES BETWEEN 02-DEC-2010 AND 18-DEC-2024. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN SIXTEEN (16) CASES DUE TO THE FOLLOWING COMPLICATIONS: THREE (3) KNEES DUE TO ARTHROFIBROSIS, THREE (3) DUE TO INSTABILITY, SEVEN (7) DUE TO LOOSENING, ONE (1) DUE TO PAIN, TWO (2) DUE TO OTHER REASONS. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR RE-REVISION. LEGION OXINIUM CONSTRAINED FEMORAL COMPONENT: IMPLANTED IN ONE THOUSAND THREE HUNDRED FIFTY-EIGHT (1358) KNEES BETWEEN 6-JUN-2006 AND 11-FEB-2025. SUBSEQUENT RE-REVISION SURGERIES WERE REPORTED IN ONE HUNDRED AND EIGHTY-EIGHT (188) CASES DUE TO THE FOLLOWING COMPLICATIONS: FIFTY-EIGHT (58) KNEES DUE TO LOOSENING, FIFTY (50) KNEES DUE TO INFECTION, TWENTY-TWO (22) KNEES DUE TO INSTABILITY, SEVENTEEN (17) KNEES DUE TO PAIN, EIGHT (8) KNEES DUE TO ARTHROFIBROSIS, FOUR (4) KNEES DUE TO MALALIGNMENT, FOUR (4) KNEES DUE TO PATELLOFEMORAL PAIN, TWO (2) KNEES DUE TO PATELLA EROSION, ONE (1) KNEE DUE TO PERIPROSTHETIC FRACTURE, ONE (1) KNEE DUE TO METAL RELATED PATHOLOGY, TWO (2) KNEES DUE TO PATELLA MALTRACKING, NINE (9) KNEES DUE TO BEARING DISLOCATION, ONE (1) KNEE DUE TO WEAR TIBIAL INSERT, ONE (1) KNEE DUE TO IMPLANT BREAKAGE TIBIAL INSERT, ONE (1) KNEE DUE TO IMPLANT BREAKAGE PATELLA, ONE (1) KNEE DUE TO PROSTHESIS DISLOCATION, ONE (1) KNEE DUE TO SYNOVITIS, AND FIVE (5) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH RE-REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH RE-REVISION CASE. ALTOGETHER, A TOTAL QUANTITY OF THREE HUNDRED AND SEVENTY-SIX (376) UKA REVISION SURGERIES, FOUR THOUSAND AND NINETY-ONE (4,091) TKA REVISION SURGERIES AND FOUR HUNDRED AND EIGHT (408) RE-REVISION SURGERIES HAVE BEEN REPORTED IN THE AOANJRR FOR THE SMITH+NEPHEW DEVICES REFERENCED ABOVE. THIS RESULTS IN A CUMULATIVE TOTAL OF FOUR THOUSAND EIGHT HUNDRED AND SEVENTY-FIVE (4,875) EVENTS SUMMARIZED IN THE CURRENT 3500A FORM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
65047		PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 17

• Arthralgia
• Arthrofibrosis
• Aseptic loosening
• Bone Fracture(s)
• Deformity/ Disfigurement
• Erosion
• Extraskeletal ossification
• Insufficient Information
• Joint Dislocation
• Joint Laxity
• Metal Related Pathology
• Necrosis
• Osteolysis
• Pain
• Periprosthetic fracture
• Synovitis
• Unspecified Infection

Product problems · 7

• Adverse Event Without Identified Device or Use Problem
• Fracture
• Improper or Incorrect Procedure or Method
• Loosening of Implant Not Related to Bone-Ingrowth
• Malposition of Device
• Material Erosion
• Osseointegration Problem

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission